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临床试验/CTRI/2025/07/091086
CTRI/2025/07/091086尚未招募3 期

Evaluation of safety and efficacy of conjunctival autograft with adjuvants in comparison to conjunctival limbal autograft technique- A randomised control study

ESIC Medical College and Hospital, Sanathnagar, Hyderabad1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Recurrence rates of Pterygium and complications

研究概览

简要总结

Randomised control study conducted over a period of one year including patients aged 20 - 70 years presenting with primary pterygium of any grade. 90 patients will be divided into three groups A B and C by simple randomisation . Group A patients will undergo pterygium excision with conjunctival limbal autograft technique. Group B patients will be treated by pterygium excision with conjunctival autograft and intra operative Mitomycin C. Group C patients will be treated by pterygium excision with conjunctival autograft following pre operative subconjunctival Bevacizumab injection. Patients will be followed up on post operative day one, one week , one month, 3 months, 6 months and one year post surgery. At  each follow up patient will be assessed for visual acuity, post surgery complications, including recurrence

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 70.00 Year(s)(—)
性别
All

入选标准

  • Age 20- 70 years presenting with primary pterygium of any grade.

排除标准

  • Patients allergic to Anesthetic drugs,Antimetabolites and Anti VEGFs, recurrent pterygium,scleral thinning, Acute inflammatory diseases of the eye,severe dry eye,Pregnancy,Hypertension,Cardiac issues and Coagulopathies,Cranial nerve palsies involving extra ocular muscles,Glaucoma,patients not willing to participate in the study.

结局指标

主要结局

Recurrence rates of Pterygium and complications

时间窗: 1 year

次要结局

未报告次要终点

研究者

发起方
ESIC Medical College and Hospital, Sanathnagar, Hyderabad
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dharani Padam

ESIC Medical College and hospital, Sanathnagar, Hyderabad

研究点 (1)

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