IRCT2015101024459N1.
Trial name or title | Evaluation of the efficacy of Ahmed Glaucoma Valve Implantation with and without Mitomycin C during surgery in patients with glaucoma |
Methods |
Study design: parallel group, randomized controlled trial Planned enrolment: 60 participants Unit of analysis: participant (one study eye per participant) Sample size calculation: not reported |
Participants |
Country: Iran Inclusion criteria: 18 years of age or older; uncontrolled glaucoma; candidate for aqueous shunt surgery Exclusion criteria: active iris neovascularization, anterior staphyloma, breastfeeding, pregnancy, previous shunt surgery, corneal lesions that prevent IOP measurement |
Interventions |
MMC group: 1‐stage Ahmed valve implant with MMC (0.02%) No MMC group: Ahmed valve implant with placebo (balanced salt solution) |
Outcomes |
Primary outcome: IOP Secondary outcomes: tube‐corneal contact, number of antiglaucoma medications, hyphema, retraction of tube from anterior chamber, tube/implant exposure, flat chamber/transient hypotony, choroidal effusion, blocked tube Length of follow‐up: postoperative day 1, week 1, and months 1, 3, 6, and 12 |
Starting date | November 2015 |
Contact information | Dr. Ghasem Fakhraee Farabi Eye Hospital Tehran University of Medical Sciences |
Notes | Conflicts of interest: not reported |