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. 2019 Apr 19;2019(4):CD011875. doi: 10.1002/14651858.CD011875.pub2

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