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

NCT02989207.

Trial name or title Surgical approaches in treating uncontrolled glaucoma in black African and African‐Caribbeans (PEACE)
Methods Study design: parallel group, randomized controlled trial
Planned enrolment: 60 participants
Unit of analysis: not reported
Sample size calculation: not reported
Participants Country: UK
Inclusion criteria: 18 to 85 years of age, black African Caribbean or African (self‐reported), uncontrolled glaucoma (IOP between 18 and 40 mmHg)
Exclusion criteria: breastfeeding, pregnancy, previous incisional surgery (except for phacoemulsification or minimally invasive glaucoma shunt surgery), no light perception vision, active diabetic retinopathy, secondary glaucoma, unwilling to discontinue contact lens use post‐surgery, conjunctival scarring (precluding superior trabeculectomy), functionally significant cataract likely to require surgery within 6 months of glaucoma surgery, previous complicated cataract surgery in study eye, need for glaucoma surgery with other ocular procedures, iris neovascularization or proliferative retinopathy, iridocorneal endothelial syndrome, epithelial or fibrous downgrowth, chronic or recurrent uveitis, steroid‐induced glaucoma, severe posterior blepharitis
Interventions MMC group: Baerveldt tube surgery with MMC (0.02%)
No MMC group: Baerveldt tube surgery without MMC
Other group: trabeculectomy with MMC
Outcomes Primary outcome: the number of potential participants enrolled over a set time
Secondary outcomes: success rate, defined as eyes that have not failed and are not on supplemental medical therapy; failure rate, defined as IOP > 21 mmHg or not reduced by 20% below baseline on two consecutive follow‐up visits, additional glaucoma surgery, loss of vision, or IOP < 5 mmHg on two consecutive follow‐up visits; complication rate; the number of extra unscheduled clinic visits and unplanned procedures; loss to follow‐up rate; response rates to the self‐report
Length of follow‐up: up to 6 months
Starting date August 2016
Contact information Sheng Lim, MD; Stephanie Jones
 Guy's and St Thomas' NHS Foundation Trust
Notes Conflicts of interest: not reported

IOP: intraocular pressure
 MMC: mitomycin C