Clinical Trial

Conventional Non-Penetrating Deep Sclerectomy Versus Modified Subflap Mattress Suture in OAG

Completed
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Summary
The goal of this clinical trial is to learn if modified non-penetrating deep sclerectomy (NPDS) with a sub-flap mattress suture works to treat open-angle glaucoma (OAG). It will also learn about the safety and effectiveness of this modified surgical approach. The main questions it aims to answer are: Does the modified NPDS technique result in significantly lower and more persistent intraocular pressure (IOP) reduction compared to the conventional technique? What is the rate of complete success (IOP 6-18 mmHg without medication) and qualified success (IOP 6-18 mmHg with medication) for both groups? What postoperative complications or medical problems (such as iris prolapse, conjunctival leaks, or IOP spikes) do participants experience? Researchers will compare Modified Deep Sclerectomy with Ahmed's sub-flap mattress suture to standard conventional NPDS to see which technique provides better long-term pressure control. Participants will be randomized into two groups and will: Undergo either the standard NPDS procedure or the modified NPDS procedure using a 10/0 nylon mattress suture. Visit the clinic for at least five scheduled follow-up appointments at 1 week, 1 month, 3 months, 6 months, and 9 months post-surgery. Undergo comprehensive eye examinations at each visit, including Goldmann applanation tonometry for IOP, visual acuity testing, and monitoring for the development of cataracts or other surgical complications.
Trial Details
NCT Number NCT07425743
Lead Sponsor Beni-Suef University
Conditions Open Angle Glaucoma (OAG)
Enrollment 26 participants
Start Date 2022-11-07
Primary Completion 2024-08-01 (estimated)
Study Completion 2024-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-23