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Short-Term Efficacy and Safety of Combined Deep Sclerectomy With Trabeculotomy in Advanced Glaucoma: A Prospective Interventional Study
Sponsor: Minia University
Summary
\*\*Brief Summary\*\* Glaucoma is a progressive eye disease that can lead to irreversible vision loss if intraocular pressure (IOP) is not adequately controlled. Some patients with advanced glaucoma require surgery when medications and/or laser treatment fail to achieve the desired pressure reduction. This prospective, single-center interventional study aims to evaluate the short-term effectiveness and safety of a combined glaucoma surgery involving deep sclerectomy, trabeculotomy. The study will include 20 eyes of eligible adult patients with advanced glaucoma who require surgical treatment to lower intraocular pressure. All participants will undergo the planned surgical procedure and receive postoperative care according to a standardized protocol. Follow-up examinations will be performed on the first postoperative day, at one week, and at one, three, and six months after surgery. The primary outcome will be the change in intraocular pressure from baseline to three months after surgery. Secondary outcomes will include changes in the number of glaucoma medications required, visual acuity, surgical success, the need for additional treatment, and the occurrence of intraoperative or postoperative complications. The findings are expected to provide information about the short-term effectiveness and safety of this modified surgical technique in patients with advanced glaucoma. As a single-center study without a comparison group, the results will be interpreted in the context of its design and sample size.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
16
Start Date
2025-09-15
Completion Date
2026-10-05
Last Updated
2026-10-26
Healthy Volunteers
No
Interventions
Combined Deep Sclerectomy with Trabeculotomy
Participants with advanced glaucoma requiring surgical intraocular pressure reduction will undergo combined deep sclerectomy and trabeculotomy . The procedure involves creation of superficial and deep scleral flaps, removal of deep scleral tissue to expose the trabeculo-Descemet membrane, trabeculotomy to enhance aqueous outflow, and placement of a sub-flap mattress suture to maintain controlled separation between the superficial scleral flap and the underlying scleral bed. The conjunctiva will be closed watertight. All participants will receive standardized postoperative treatment and follow-up examinations for six months. The intervention will be evaluated for its effect on intraocular pressure, antiglaucoma medication requirements, visual acuity, surgical success, and postoperative complications.
Locations (1)
Al azhar university
Minya, Egypt