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

NCT07425743 | Completed DMC

• 1 other identifier: FMBSUREC/06112022/Orabi
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Open Angle Glaucoma (OAG)

Keywords

Open Angle Glaucoma (OAG); Nonpenetrating Deep Sclerotomy (NPDS); Sub-Flap Mattress sutures; Ahmed's Sutures

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure (IOP)

  IOP was measured using Goldmann applanation tonometry (GAT) at baseline (1 day preoperative) and during the planned follow-up visits.

  From baseline (1 day preoperative) to the five follow-up visits at one week, one month, three months, six months, and nine months.

Secondary Outcomes (5)

• The Percentage of Patients with Postoperative IOP within 6-18 mmHg without Medication

  At one week, one month, three months, six months, and nine months postoperatively.

• Best Corrected Visual Acuity (BCVA)

  From baseline 1 day preoperative and the five follow-up visits at one week, one month, three months, six months, and nine months.

• Postoperative Complications

  At one week, one month, three months, six months, and nine months postoperatively.

• Need for Reintervention

  At one week, one month, three months, six months, and nine months postoperatively.

• Postoperative Medication

  At one week, one month, three months, six months, and nine months postoperatively.

Study Arms (2)

Group A (Conventional NPDS)

ACTIVE COMPARATOR

The standard procedure

Procedure: Conventional Nonpenetrating Deep Sclerectomy (NPDS)

Group B (Modified NPDS)

EXPERIMENTAL

Modified NPDS with Ahmed's sub-flap mattress suture

Procedure: Modified Deep Sclerectomy with Ahmed's sub-flap mattress suture (modified NPDS)

Interventions

Modified Deep Sclerectomy with Ahmed's sub-flap mattress suture (modified NPDS) PROCEDURE

Up until the deep scleral flap was removed, this method was identical to the conventional NPDS. Applying a mattress suture beneath the superficial scleral flap was the next step. The superficial flap was sutured with a 10/0 nylon (Alcon®) that extended 1 mm beyond its outside edges. The methodology originally described by Abdel Rahman and Habib was followed by the placement method. The initial step in introducing the suture into the sclera was to line it with the left boundary of the superficial scleral flap and to do it in an anteroposterior manner. This was done 2 mm outside the flap. After that, it was moved horizontally under the flap again until it reached the right border. Then, it was threaded postero-anteriorly, 2 mm laterally to the right flap edge. Then, using McPherson forceps, the suture was fastened in a mattress configuration, with one limb placed near Schlemm's canal.

Group B (Modified NPDS)

Conventional Nonpenetrating Deep Sclerectomy (NPDS) PROCEDURE

The conjunctiva was made more visible by placing a 7/0 Vicryl corneal traction suture in the superior cornea. Wescott scissors were used to excise a 10 mm fornix-based conjunctival flap, and minimum diathermy was used to achieve haemostasis. Using a super blade, a 4 mm x 4 mm superficial scleral flap was made. Then, a crescent knife was used for anterior dissection to a depth of around 50% of the scleral thickness, exposing the top 2 mm of the transparent cornea. Under the scleral flap in the subconjunctival area, mitomycin-C (MMC®) sponges were positioned at a concentration of 0.2 mg/mL and moved towards the upper fornix. They were kept in place for 2 minutes. A balanced salt solution, volume 50 mL, was used for irrigation purposes. The scleral spur was located by dissecting a deep scleral flap that began at the superficial flap's perimeter and continued to a depth equal to 90% of the thickness of the scleral bed. To expose the trabecular meshwork (TDM), the roof of Schlemm's canal wa

Group A (Conventional NPDS)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with primary or secondary open-angle glaucoma (OAG), either uncontrolled or intolerant to medical therapy

You may not qualify if:

• Past glaucoma procedures, including laser therapy, lens extraction, previous refractive surgery, angle closure, and neovascular glaucoma.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (2)

Beni-Suef University Hospital

Banī Suwayf, Beni Suweif Governorate, 62511, Egypt

Location

The Glaucoma Department at the Memorial Institute for Ophthalmic Research

Giza, Giza Governorate, Egypt

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Amr Taha Orabi

  Beni-Suef University

  PRINCIPAL INVESTIGATOR

• Mohamed Sayed Abouzeid, MD

  Beni-Suef University

  STUDY DIRECTOR

• Hazem Haroun

  Beni-Suef University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 23, 2026
• Study Start: November 7, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)