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临床试验/CTRI/2024/07/071585
CTRI/2024/07/071585尚未招募不适用

Comparing Preoperative Versus Intraoperative role of Subpterygial Mitomycin C Injection in Preventing Recurrence of Pterygium reccurence in North West Indian population: A randomized Control Trial

Dr Sahil Jain1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2024年8月5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
78
试验地点
1
主要终点
To observe efficacy of preoperative subterygial mitomycin-c injection as compared to intraoperative subpterygial mitomycin-c injection in preventing pterygium recurrence

研究概览

简要总结

Pterygium recurrence is extremely common (30–80%), making it the most common complication following surgery. As a result, various techniques, including conjunctival autografting, intra- or post-operative adjuvant Mitomycin-C (MMC), and amniotic membrane transplantation, are being evaluated in an attempt to reduce this high recurrence rate.

MMC is an alkylating agent which inhibits the transcription of DNA into RNA. This in turn stops protein synthesis and reduces cellular migration and proliferation. It is an antitumor antibiotic that was isolated from Streptomyces caespitosus.

As Bathinda is at a geographical location where weather conditions are hot, and dry during summer season the prevalence of pterygium is high in the population of this region. Therefore, we are conducting this study in ALL INDIA INSTITUTE OF MEDICAL SCIENCES ,BATHINDA .In this study we will compare efficacy of bare sclera technique with 1 month prior preoperative MMC subpterygial injection  vs intra-op MMC injection with bare sclera technique.

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
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • All pterygium Patient age more than 18 years.
  • All those willing to give written consent to participate in study.
  • Primary pterygium.

排除标准

  • Any Pre-existing Scleral disease or on its medication
  • Patients with anterior uveitis or anterior/posterior staphyloma
  • Any intraocular surgery or laser in recent 1 month.

结局指标

主要结局

To observe efficacy of preoperative subterygial mitomycin-c injection as compared to intraoperative subpterygial mitomycin-c injection in preventing pterygium recurrence

时间窗: At 3rd month of surgical excision

次要结局

  • To evaluate demographic & clinical characteristics of pterygium(AT day 0 end of 1st month & 3rd month of surgical excision)

研究者

发起方
Dr Sahil Jain
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sahil Jain

AIIMS BATHINDA

研究点 (1)

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