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. 2015 Dec 1;2015(12):CD010472. doi: 10.1002/14651858.CD010472.pub2

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
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
Interventions Intervention 1: trabeculectomy + Ologen (brand not reported)
Intervention 2: trabeculectomy + MMC
Length of follow‐up:
Planned: not reported
 Actual: 12 months
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
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
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