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临床试验/CTRI/2023/03/050317
CTRI/2023/03/050317尚未招募不适用

Microkeratome assisted vs femtosecond laser assisted sutureless anterior lamellar keratoplasty for superficial corneal opacities: A randomized control trial

Army Hospital Research and Referral1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年9月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
72
试验地点
1
主要终点
Visual acuity - measured using logMAR charts.

研究概览

简要总结

Preoperatively, slit lamp examination/anterior segment OCT will be done to know the depth of the opacity and for the purpose of documentation. Patients will be divided into two groups by computer generated randomization. In the first treatment arm, patients will undergo microkeratome-assisted anterior lamellar keratoplasty in main OT. In the second treatment arm, patients will undergo femtosecond laser-assisted anterior lamellar keratoplasty in Femto OT. Patients will be followed postoperatively on the next day, after 1 week, after 1 month, after 3 months and after 6 months.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Investigator Blinded

入排标准

年龄范围
1.00 Day(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Corneal scar secondary to infection Corneal scar secondary to trauma Spheroidal degeneration Band shaped keratopathy Corneal dystrophy involving superficial 200 µm thickness.

排除标准

  • Corneal opacity involving more than 200 µm corneal thickness.

结局指标

主要结局

Visual acuity - measured using logMAR charts.

时间窗: pre-operative | post-operative day-1 | week 1 | week 4 | week 12 | week 24

Contrast sensitivity.

时间窗: pre-operative | post-operative day-1 | week 1 | week 4 | week 12 | week 24

Corneal aberrations using Sirius Tomogram.

时间窗: pre-operative | post-operative day-1 | week 1 | week 4 | week 12 | week 24

次要结局

  • K-readings using Sirius Tomogram.(AS-OCT.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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