Maheshwari 2012.
Methods |
Study design: parallel‐group randomized controlled trial Number randomized: 40 eyes of 40 participants total; 20 eyes of 20 participants in each group Exclusions after randomization: none reported Losses to follow‐up: none reported Unit of analysis: individual (1 eye per participant) Number analyzed: 40 eyes of 40 participants total; 20 eyes of 20 participants in each group How were missing data handled?: no missing data Power calculation: not reported |
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Participants |
Country: India Age: not reported Gender: not reported Inclusion criteria: requiring glaucoma surgery for uncontrolled IOP in POAG Exclusion criteria: ACG, post‐traumatic,uveitic, neovascular, or dysgenetic glaucoma; allergy to collagen, preliminary conjunctival damage (trauma, vitreo–retinal surgery, previous glaucoma surgery, and other); under 18 years of age Equivalence of baseline characteristics: no; at 1 year, a mean IOP of 15.6 mm Hg in the Ologen group was with 43% reduction and a mean IOP of 10.5 mm Hg in the trabeculectomy group was with 50% group; based on this information, the baseline IOP in Ologen group seemed to be about 30% more than the trabeculectomy group |
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Interventions |
Intervention 1: trabeculectomy + Ologen (brand not reported) Intervention 2: trabeculectomy + MMC Length of follow‐up: Planned: not reported Actual: 12 months |
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Outcomes | Primary and secondary outcomes not distinguished Outcome, as reported: visual acuity, IOP measurement, filtering bleb, and complications Intervals at which outcomes assessed: 1 day and 1 year after the surgery |
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Notes |
Publication type: published article Funding sources: not reported Disclosures of interest: not reported Trial registry: not registered Study period: not reported Subgroup analyses: none reported Publication language: English Authors not contacted |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Random sequence generation was not reported |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment was not reported |
Masking of participants and personnel (performance bias) | Unclear risk | Masking of participants and personnel was not reported |
Masking of outcome assessment (detection bias) | High risk | Not reported. Although it is not possible to mask outcome assessors, devices can be easily seen during examination of the eye |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The number of participants with missing or incomplete outcome assessment was not reported |
Selective reporting (reporting bias) | Unclear risk | Protocol was not available. Visual acuity and filtering bleb were defined in the Methods section, but the results were not reported |
Other bias | Unclear risk | Did not report source of funding or conflict of interest. The baseline IOP seemed not equivalent between the 2 groups. At 1 year, a mean IOP of 15.6 mm Hg in the Ologen group was with 43% reduction and a mean IOP of 10.5 mm Hg in the trabeculectomy group was with 50% group; based on this information, the baseline IOP in the Ologen group seemed to be about 30% more than the trabeculectomy group |