跳至主要内容
临床试验/CTRI/2025/09/094844
CTRI/2025/09/094844尚未招募不适用

Efficacy of Gonioscopy-Assisted Transluminal Trabeculotomy in Open Angle Galucoma

Maulana Azad medical College1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2025年9月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
23
试验地点
1
主要终点
Number of eyes with complete success of GATT in OAG [defined as IOP less then 18 mmHg or 20% reduction without anti-glaucoma medication (AGM)]

研究概览

简要总结

Gonioscopy assisted transluminal trabeculotomy (GATT) is a type of minimally invasive glaucoma surgery. In this study patients will be recruited as per inclusion criteria. Those patient needing cataract surgery will under go combined phacoemulsification with GATT and those not requiring cataract surgery will undergo GATT alone. After the surgery patients will follow up till 4 months and see if there’s any, change in IOP, number of anti-glaucoma medication, mean deviation in visual field HVF 24-2, central corneal thickness, fundus examination and complications post operative if any, at different time periods post operative. All the data collected will be evaluated to check for primary and secondary outcome. This study will provide us sufficient data to evaluate the efficacy of GATT.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Moderate to advanced open angle glaucoma.
  • Pseudoexfoliation andpigmentary glaucoma (moderate to severe).
  • Patients with visually significant cataract requiring cataract surgery whose visual acuity is less then or equal to 6/
  • Pseudophakic patients with more than 3 months history of cataract surgery.

排除标准

  • 1.Mono-ocular patients or one eyed patients.
  • Patient with history of ocular trauma or previous ocular surgery, other than cataract surgery.
  • Patience on anticoagulants.
  • Patients who have corneal pathology or previous corneal refractive Surgery, which will affect the visualisation of angle on gonioscopy and IOP measurement.

结局指标

主要结局

Number of eyes with complete success of GATT in OAG [defined as IOP less then 18 mmHg or 20% reduction without anti-glaucoma medication (AGM)]

时间窗: 3 Months, 4Months

次要结局

  • To evaluate the Number of eyes with qualified success of GATT in OAG (defined as IOP less than 18 mmHg or 20% reduction with use of AGM) at 3 months and 4 months. Mean IOP change/reduction post operatively at 3 months and 4 months. Mean change/reduction in the number of anti-glaucoma medications at 3 months and 4 months.(3 months and 4 months)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Nitin Gaba

Maulana Azad medical College

研究点 (1)

Loading locations...

相似试验