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临床试验/NCT07542522
NCT07542522已完成不适用

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

Cairo University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
IOP reduction

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Months 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: gonioscopy assissted transluminal trabeculotomy (Procedure)

结局指标

主要结局

IOP reduction

时间窗: 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

Change in Number of Antiglaucoma Medications

时间窗: 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.

次要结局

  • surgical success(12 month postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marwa Elsayed Soliman Ahmed

9th kamal wadee eskander street - ezz elden omar - haram - Giza assistant lecturer in kasr alainy cairo university

Cairo University

研究点 (1)

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