- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07542522
Outcome of Gonioscopy-Assisted Transluminal Trabeculotomy in Pediatric Glaucoma Following Cataract Surgery. ((GATT in GFCS))
Outcome of Gonioscopy-Assisted Transluminal Trabeculotomy in Glaucoma Following Pediatric Cataract Surgery. A Prospective Interventional Case Series.
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Giza Governorate
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Cairo, Giza Governorate, Egypt, 8888
- Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Pediatric glaucoma following cataract surgery
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.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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IOP reduction
Time Frame: 12 month post operative
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Change in intraocular pressure (IOP) from baseline to 12 months after gonioscopy-assisted transluminal trabeculotomy (GATT) in pediatric eyes with glaucoma following cataract surgery
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12 month post operative
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Change in Number of Antiglaucoma Medications
Time Frame: 12 month postoperatively
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Change in the number of antiglaucoma medications used from baseline to 12 months after GATT in pediatric eyes with glaucoma following cataract surgery.
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12 month postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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surgical success
Time Frame: 12 month postoperatively
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Success was defined as final IOP ≤21 mmHg without further glaucoma intervention and absence of vision-threatening complications.
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12 month postoperatively
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marwa E Soliman, Cairo University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MD-196-2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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