Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Characteristics of ongoing studies [ordered by study ID]

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques: Infection

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: CHARACTERISTICS OF STUDIES Characteristics of included studies [ordered by study ID]

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques: Sequencing, Selection, Filtration, Generated, Blocking Assay, Functional Assay, Lysis, Introduce

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: SUMMARY OF FINDINGS FOR THE MAIN COMPARISON [ Explanation ]

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: ADDITIONAL SUMMARY OF FINDINGS [ Explanation ]

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Comparison 1 Trabeculectomy (Trab) + Ex-PRESS versus Trabeculectomy (Trab), Outcome 1 Postoperative IOP at one year.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Forest plot of comparison: 2 Trabeculectomy + Ex-PRESS versus Trabeculectomy, outcome: Postoperative IOP at one year.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Comparison 1 Trabeculectomy (Trab) + Ex-PRESS versus Trabeculectomy (Trab), Outcome 2 Postoperative IOP at six months.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Comparison 1 Trabeculectomy (Trab) + Ex-PRESS versus Trabeculectomy (Trab), Outcome 3 Postoperative IOP at two years.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Comparison 1 Trabeculectomy (Trab) + Ex-PRESS versus Trabeculectomy (Trab), Outcome 4 Postoperative logMAR BCVA at one year.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Comparison 1 Trabeculectomy (Trab) + Ex-PRESS versus Trabeculectomy (Trab), Outcome 5 Complications.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Comparison 2 Trabeculectomy (Trab) + Ologen versus Trabeculectomy (Trab), Outcome 1 IOP at one year.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Forest plot of comparison: 2 Trabeculectomy (Trab) + Ologen versus Trabeculectomy (Trab), outcome: 2.1 IOP at one year.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Comparison 2 Trabeculectomy (Trab) + Ologen versus Trabeculectomy (Trab), Outcome 2 Postoperative IOP at day one.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Comparison 2 Trabeculectomy (Trab) + Ologen versus Trabeculectomy (Trab), Outcome 3 Postoperative IOP at six months.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Comparison 2 Trabeculectomy (Trab) + Ologen versus Trabeculectomy (Trab), Outcome 4 Postoperative IOP at two years.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Comparison 2 Trabeculectomy (Trab) + Ologen versus Trabeculectomy (Trab), Outcome 5 Complications.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Comparison 3 Trabeculectomy (Trab) + AMT (amniotic membrane) versus Trabeculectomy (Trab), Outcome 1 Postoperative IOP at one year.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Forest plot of comparison: 4 Trabeculectomy + AMT (amniotic membrane) versus Trabeculectomy, outcome: 4.1 Postoperative IOP at one year.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Comparison 3 Trabeculectomy (Trab) + AMT (amniotic membrane) versus Trabeculectomy (Trab), Outcome 2 Postoperative IOP at one day.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Comparison 3 Trabeculectomy (Trab) + AMT (amniotic membrane) versus Trabeculectomy (Trab), Outcome 3 Postoperative IOP at one week.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Comparison 3 Trabeculectomy (Trab) + AMT (amniotic membrane) versus Trabeculectomy (Trab), Outcome 4 Postoperative IOP at one month.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Comparison 3 Trabeculectomy (Trab) + AMT (amniotic membrane) versus Trabeculectomy (Trab), Outcome 5 Postoperative IOP at three months.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Comparison 3 Trabeculectomy (Trab) + AMT (amniotic membrane) versus Trabeculectomy (Trab), Outcome 6 Postoperative IOP at six months.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Comparison 3 Trabeculectomy (Trab) + AMT (amniotic membrane) versus Trabeculectomy (Trab), Outcome 7 Postoperative IOP at two years.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Comparison 3 Trabeculectomy (Trab) + AMT (amniotic membrane) versus Trabeculectomy (Trab), Outcome 8 Complications.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Comparison 4 Trabeculectomy (Trab) + E-PTFE versus Trabeculectomy (Trab), Outcome 1 Postoperative IOP at one year.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Forest plot of comparison: 1 Trabeculectomy + E-PTFE versus Trabeculectomy, outcome: 1.1 Postoperative IOP at one year.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Comparison 4 Trabeculectomy (Trab) + E-PTFE versus Trabeculectomy (Trab), Outcome 2 Hypotony at 24 months.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Comparison 4 Trabeculectomy (Trab) + E-PTFE versus Trabeculectomy (Trab), Outcome 3 Hyphaema at 24 months.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Comparison 4 Trabeculectomy (Trab) + E-PTFE versus Trabeculectomy (Trab), Outcome 4 Inflammation at 24 months.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Comparison 4 Trabeculectomy (Trab) + E-PTFE versus Trabeculectomy (Trab), Outcome 5 Shallow anterior chamber at 24 months.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Comparison 4 Trabeculectomy (Trab) + E-PTFE versus Trabeculectomy (Trab), Outcome 6 Flat anterior chamber at 24 months.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques:

Journal: The Cochrane database of systematic reviews

Article Title: Device-modified trabeculectomy for glaucoma

doi: 10.1002/14651858.CD010472.pub2

Figure Lengend Snippet: Comparison 4 Trabeculectomy (Trab) + E-PTFE versus Trabeculectomy (Trab), Outcome 7 Choroidal detachment at 24 months.

Article Snippet: : no missing data Power calculation: not reported Participants Country: Egypt Mean age: 50 years; 50.2 years for trabeculectomy + Ologen® group; 49.7 years for trabeculectomy + MMC group Gender: 35/60 (%) men and 25/60 (%) women; 18/30 (%) men and 12/30 (%) women in trabeculectomy + Ologen® group; 17/30 (%) men and 13/30 (%) women in trabeculectomy + MMC group Inclusion criteria: “POAG, chronic angle-closure glaucoma (CACG), uveitic glaucoma, pseudoexfoliation glaucoma (PEXG), and pseudophakic glaucoma not controlled medically (more than 21 mm Hg despite medications)” Exclusion criteria: “neovascular glaucoma, age < 18, and previous ocular surgery or laser procedures” Equivalence of baseline characteristics: yes Interventions Intervention 1: trabeculectomy + Ologen® (Aeon Astron Group B.V. Leiden, The Netherlands) Intervention 2: trabeculectomy + MMC Length of follow-up: Planned: 12 months Actual: 12 months Outcomes Primary and secondary outcomes not distinguished Outcome, as reported: IOP, bleb status, complications, absolute success (IOP ≤ 21 mm Hg without topical medication), and qualified success (IOP ≤ 21 mm Hg with topical medication) Intervals at which outcomes assessed: 1, 3, 6, 9, and 12 months after surgery Notes Publication type: published article Funding sources: not reported Disclosures of interest: ”no competing financial interests exist“ Trial registry: not registered Study period: February 2009 to January 2011 Subgroup analyses: none reported Publication language: English Authors not contacted Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Unclear risk “Participants were randomly enrolled in 2 groups.” The method of sequence generation is not described, thus its adequacy cannot be judged Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported Masking of participants and personnel (performance bias) Low risk According to the Cochrane Handbook (8.

Techniques: