Reddy 2011.
Study characteristics | ||
Methods |
Study design: RCT (14 bilateral and 4 unilateral participants) Number randomized (total and per group): 32 eyes of 18 children; 16 in each group Number analyzed (total and per group): none (personal communication) Losses to follow‐up: none (personal communication) Length of follow‐up: Planned: 6 months Actual: 6 months Sample size calculation (Y/N): N |
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Participants |
Country: India Age: not reported Gender: not reported Inclusion criteria: primary infantile congenital glaucoma aged less than two years Exclusion criteria: secondary glaucoma; glaucoma associated with other ocular anomalies; glaucoma associated with systemic anomalies; dense corneal opacity preventing view of anterior chamber for trabeculotomy Equivalence of baseline characteristics: comparable in preoperative IOP, vertical corneal diameter, and horizontal corneal diameter |
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Interventions |
Intervention 1: trabeculotomy‐trabeculectomy with mitomycin C Mitomycin C in concentration of 0.02% is applied subconjunctivally for a period of three minutes. Intervention 2: trabeculectomy with mitomycin C Mitomycin C in concentration of 0.02% is applied subconjunctivally for a period of three minutes. In addition to trabeculectomy, a trabeculotomy is done using a Harm's trabeculotome. |
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Outcomes |
Outcomes:
Intervals at which outcome assessed: week 1 and 2, month 1, 3, and 6 Issues with outcome assessment: study included both eyes of the same participant for 14 participants, but did not consider intraperson correlation Adverse effects: yes |
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Notes |
Type of study: published Funding: none (personal communication) Declaration of interest: none (personal communication) Study period: December 2006 to June 2008 Clinical trial registry: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Trial investigator reported: "We picked up random numbers from the random tables. We randomized eyes in case of bilateral patients and randomized patients in case of unilateral patients. In bilateral cases the patients who were even numbered in randomization table had Trabeculotomy and Trabeculectomy with Mitomycin C in the right eye and odd numbered had Trabeculectomy with Mitomycin C in right eye. In unilateral cases even numbered had Trabeculotomy and trabeculectomy with Mitomycin C and odd numbered had trabeculectomy with Mitomycin C." (personal communication) |
Allocation concealment (selection bias) | Low risk | "The randomization was done our statistics department and the envelope was opened in or before starting surgery" (personal communication) |
Masking of participants and personnel (performance bias) | Unclear risk | Masking of participants and investigators to treatment was not described. |
Masking of outcome assessment (detection bias) | Unclear risk | "No masking was done to measure the outcome measures. Only thing done was we were not exposed to the case sheet in or until we took our readings. We attached the proforma to the case sheet later." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "There was no attrition" (personal communication) |
Selective reporting (reporting bias) | Unclear risk | Neither protocol nor clinical registry was available. |
Other bias | Low risk | None identified. |