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