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临床试验/CTRI/2024/04/065085
CTRI/2024/04/065085尚未招募4 期

Trabeculectomy surgery with fixed sutures vs Releasable sutures in uncontrolled Glaucoma: Prospective interventional study

未提供1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年4月14日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
24
试验地点
1
主要终点
Trabeculectomies with releasable sutures are expected to give better outcome in terms of IOP reduction and bleb morphology

研究概览

简要总结

All the Glaucoma patients in ophthalmology department fulfilling inclusion criteria after taking informed consent from the participant.Detailed clinical history of the patients will be taken. Clinical examination of the patients will be done. Visual acuity will be assessed using Snellen’s chart. Ocular examination included Anterior segment evaluation with slit-lamp IOP will be measured by using Goldman applanation tonometry. Humphry’s visual field analysis will be done. Gonioscopy will be done to grade the angle (by using Shaffer’s grading system) and to note the presence and extent of peripheral anterior synechiae. Pupils will be dilated using Tropicamide 0.8%and Phenyalephrine 5% 1 drop  every 10 min till full dilatation is achieved. Fundus examination will be done using Indirect ophthalmoscope and90D lens with slit lamp. Follow up visit postoperatively will be on day14 and 28th and at the completion of 3months. Evaluation will include recording of IBAGS bleb score by slit lamp examination, measurement of IOP by GAT.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
20.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients with more than or equal two antiglaucoma medications eventhough no change in Intraocular pressure 2.Patients with Open angled glaucoma not responding to drugs 3.Patients with primary angle closure glaucoma not responding to drugs.

排除标准

  • 1.Patients with secondary glaucoma due to uveitis, trauma, neovascular and juvenile glaucoma 2.Patients with Phacomorphic glaucoma those who need combined cataract and glaucoma surgery 3.Patients with Phacolytic glaucoma.

结局指标

主要结局

Trabeculectomies with releasable sutures are expected to give better outcome in terms of IOP reduction and bleb morphology

时间窗: Reduction in IOP on Post-OP day 14

次要结局

未报告次要终点

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Harika gajjala

AIIMS RAIPUR

研究点 (1)

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