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Completed

NCT Number: NCT07542522

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

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.

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Key information

Age range

6 month–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Giza Governorate, 8888, Egypt

About this study

12-month Outcome of Gonioscopy-assisted Transluminal Trabeculotomy in Pediatric Glaucoma Following Cataract Surgery.

Abstract Introduction Glaucoma following cataract surgery (GFCS) represents the most common vision-threatening complication after pediatric lensectomy, frequently necessitating surgical management. While ab-externo circumferential trabeculotomy has yielded promising results in previous studies, gonioscopy-assisted transluminal trabeculotomy (GATT) offers a minimally invasive, conjunctiva-sparing ab-interno approach for circumferential angle incision. This study evaluated the outcome of GATT in children diagnosed with GFCS.

Methods This prospective interventional case series included 30 eyes of 24 pediatric patients (aged 0.5-13 years) diagnosed with GFCS. We excluded eyes with 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. The primary outcomes were IOP reduction and changes in number of antiglaucoma medications; secondary outcomes were surgical success and complications. Success was defined as final IOP ≤21 mmHg without further glaucoma intervention and absence of vision-threatening complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. IOP reduction

    Time frame: 12 month post operative

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

  2. Change in Number of Antiglaucoma Medications

    Time frame: 12 month postoperatively

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

Secondary outcomes

  1. surgical success

    Time frame: 12 month postoperatively

    Success was defined as final IOP ≤21 mmHg without further glaucoma intervention and absence of vision-threatening complications.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Outcome of Gonioscopy-Assisted Transluminal Trabeculotomy in Glaucoma Following Pediatric Cataract Surgery. A Prospective Interventional Case Series.

Acronym: (GATT in GFCS)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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