The purpose of this study is to determine the reduction in intraocular pressure and cumulative incidence of complications between the standard and micro trabeculectomy surgeries 3 months after surgery.
This study is a randomized, double-masked (study participants and outcome assessors) trial. During the enrollment period, consecutive patients from LEI who are planning to have trabeculectomy surgery and who meet the study enrollment criteria will be randomized to receive standard trabeculectomy or microtrabeculectomy. The primary outcome is complications and change in intraocular pressure after a 3 month follow-up period. We will perform subgroup analyses by stratifying the population according to skin pigmentation to determine whether pigmentation is a predictor of treatment success.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
240
Fornix-based trabeculectomy with a 3x4 mm scleral flap.
Fornix-based trabeculectomy with a 2x2 mm scleral flap.
Lumbini Eye Institute, Nepal
Siddharthanagar, Nepal
RECRUITINGCumulative incidence of complications
Comparison of the cumulative incidence of complications between the treatment groups (regular and micro trabeculectomy) 3 months after surgery
Time frame: 3 months after surgery
Reduction in intraocular pressure
Comparison of the reduction in intraocular pressure between the treatment groups (regular and micro trabeculectomy) 3 months after surgery
Time frame: 3 months after surgery
Cumulative incidence of complications
Cumulative incidence of complications 6 months and 12 months after surgery will be compared between the treatment groups
Time frame: 6 and 12 months after surgery
Reduction of intraocular pressure
Reduction of intraocular pressure 6 months and 12 months after surgery will be compared between the treatment groups
Time frame: 6 and 12 months after surgery
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