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

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)

Interventions

PROCEDURE

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

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.

PROCEDURE

Conventional Nonpenetrating Deep Sclerectomy (NPDS)

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

Sponsors & Collaborators

• Beni-Suef University

  lead OTHER

Principal Investigators

• Amr Taha Orabi · Beni-Suef University

• Mohamed Sayed Abouzeid, MD · Beni-Suef University

• Hazem Haroun · Beni-Suef University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-11-07

Primary Completion

2024-08-01

Completion

2024-08-01

Countries

• Egypt

Study Locations