跳至主要内容
临床试验/CTRI/2024/12/078242
CTRI/2024/12/078242尚未招募不适用

A Prospective randomised controlled study to determine the role of preoperative subconjunctival injection mydricaine and topical diclofenac sodium in maintaining mydriasis in diabetic vitrectomy

Regional Institute of Ophthalmology1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年12月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
52
试验地点
1
主要终点
increased and consistent pupillary diameter

研究概览

简要总结

A good pupillary dilatation is essential to perform an effective posterior segment surgery. An alternate to routine topical Tropicamide and Phenylephrine is subconjunctival injection Mydricaine and topical Diclofenac Sodium given 30 minutes prior the procedure to maintain effective mydriasis till the end of 90 minutes estimated vitrectomy procedure. A Castroviejo caliper is used to measure the pre and post surgical pupillary diameter.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
25.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients diagnosed with advanced diabetic eye disease with
  • Tractional retinal detachment, tractional retinal detachment with vitreous hemorrhage, nonresolving vitreous hemorrhage of minimum 3 months duration, good glycemic control , patients with pupil briskly reacting to light.

排除标准

  • Patients who had previous vitreoretinal surgery or any intraocular procedure within 6 weeks, visually significant cataract,pregnancy, history of CVA, myocardial infarction within three months, hypertensive patients, CKD patients, patients with pupil abnormalities.

结局指标

主要结局

increased and consistent pupillary diameter

时间窗: 60 minutes of start of surgery

次要结局

未报告次要终点

研究者

发起方
Regional Institute of Ophthalmology
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr V NIVETHA

Regional Institute of Ophthalmology and Government Ophthalmic Hospital

研究点 (1)

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