Outcome of Gonioscopy-Assisted Transluminal Trabeculotomy in Pediatric Glaucoma Following Cataract Surgery.

NCT07542522 | Completed DMC

• 1 other identifier: MD-196-2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective case series evaluated the 12-month outcomes of gonioscopy-assisted transluminal trabeculotomy (GATT) in children with glaucoma following cataract surgery (GFCS). Glaucoma following pediatric cataract surgery is a recognized postoperative complication that may require surgical management when medical therapy is insufficient. Gonioscopy-assisted transluminal trabeculotomy (GATT) is a minimally invasive conjunctiva-sparing procedure designed to improve aqueous outflow through circumferential trabeculotomy. This prospective interventional case series will evaluate outcomes of GATT in eligible pediatric patients with glaucoma following cataract surgery treated at Cairo University Hospitals. Participants will undergo preoperative ophthalmic assessment, standardized surgical intervention, and scheduled postoperative follow-up visits. Outcomes to be assessed include intraocular pressure, use of glaucoma medications, and safety parameters during follow-up.

Conditions

Glaucoma Following Pediatric Cataract Surgery

Keywords

GATT - GFCS

Outcome Measures

Primary Outcomes (2)

• IOP reduction

  Change in intraocular pressure (IOP) from baseline to 12 months after gonioscopy-assisted transluminal trabeculotomy (GATT) in pediatric eyes with glaucoma following cataract surgery

  12 month post operative

• Change in Number of Antiglaucoma Medications

  Change in the number of antiglaucoma medications used from baseline to 12 months after GATT in pediatric eyes with glaucoma following cataract surgery.

  12 month postoperatively

Secondary Outcomes (1)

• surgical success

  12 month postoperatively

Study Arms (1)

Pediatric glaucoma following cataract surgery

EXPERIMENTAL

All enrolled pediatric eyes with glaucoma following cataract surgery underwent gonioscopy-assisted transluminal trabeculotomy (GATT) as the sole intervention. No comparison or control group was included.

Procedure: gonioscopy assissted transluminal trabeculotomy

Interventions

gonioscopy assissted transluminal trabeculotomy PROCEDURE

The operating microscope is tilted 45 degrees,, the head of the bed is elevated, and the head of the patient is tilted to the opposite side. While sitting on the temporal side of the patient a temporal corneal incision is created by a 23 Gauge MVR. An inferior or superior paracentesis is created. The anterior chamber (AC) is filled using cohesive viscoelastic then the angle is visualized by direct gonioscopy using Swan Jacob lens. Nasal goniotomy for 2 clock is performed by using MVR blade to incise the inner wall of Schlemm's canal. Cohesive OVD is used to open the lips of the incision, then 5/0 prolene after being blunted by cautery pen is threaded inside Schlemm's canal guided it inside the canal using 23-gauge vitreoretinal forceps until we retrieve it from the opposite end of the incision. The two ends of the 5/0 prolene suture are pulled to incise the Schlemm's canal and trabecular meshwork over 360°.The AC is washed by BSS followed by injection of air to tamponade any bleeding t

Pediatric glaucoma following cataract surgery

Eligibility Criteria

• Age: 6 Months - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• pediatric glaucoma following cataract surgery with clear cornea allowing visualization of the angle

You may not qualify if:

• opaque corneas, extensive synechial angle closure, eyes in which \>180° incision could not be achieved and patients who could not complete a 12-month follow-up period

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Giza Governorate, 8888, Egypt

Location

Related Publications (3)

• 3- Grover DS, Godfrey DG, Smith O, Feuer WJ, de Oca IM, Fellman RL. Gonioscopy-assisted transluminal trabeculotomy, ab interno trabeculotomy: technique report and preliminary results. Ophthalmology. 2014;121(4):855-861.

  RESULT

• 2- El Sayed YM, Elhusseiny AM, Gawdat GI, Elhilali HM. One-year results of two-site trabeculotomy in paediatric glaucoma following cataract surgery. Eye (Lond). 2021;35(6):1637-1643.

  RESULT

• 1- Freedman SF, Beck AD, Nizam A, et al. Glaucoma-related adverse events at 10 years in the Infant Aphakia Treatment Study: a secondary analysis of a randomized clinical trial. JAMA Ophthalmol. 2021;139(2):165-173.

  RESULT

Study Officials

• Marwa E Soliman

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 9th kamal wadee eskander street - ezz elden omar - haram - Giza assistant lecturer in kasr alainy cairo university

Model Details: This was a single-group interventional study in which all enrolled eyes underwent gonioscopy-assisted transluminal trabeculotomy (GATT) without a comparison group.

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 21, 2026
• Study Start: May 20, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

EG (1)