跳至主要内容
临床试验/CTRI/2018/04/012951
CTRI/2018/04/012951已完成3 期

Safety and efficacy of transepithelial phototherapeutic keratectomy with accelerated corneal collagen cross linking in Keratoconus.

Giridhar Eye Institute1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年7月25日最近更新:

试验速览

阶段
3 期
状态
已完成
入组人数
50
试验地点
1
主要终点
To study the safety and efficacy of transepithelial phototherapeutic keratectomy (t-PTK) with accelerated corneal collagen cross linking (ACXL) in Keratoconus.

研究概览

简要总结

This is a prospective observational study to study the safety and efficacy of transepithelial phototherapeutic keratectomy (t-PTK) with accelerated corneal collagen cross linking in Keratoconus. Patients attending the cornea services of Giridhar Eye Institute and diagnosed as having keratoconus will be selected. 50 consecutive cases of keratoconus which undergoes t-PTK with ACXL will be included in the study.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • (b) Diagnosed as Keratoconus (b) Steepest keratiometry more than 47D (c) Corneal thinnest point 400 micron or more (d) Age 18 years to 50 years.

排除标准

  • (a) History or corneal disease (b) Corneal thinnest point less than 400 micron (c) Patient not willing or unable to return for schedule of protocol visits (d) Any associated ocular co-morbidities (e) Age less than 18 years.

结局指标

主要结局

To study the safety and efficacy of transepithelial phototherapeutic keratectomy (t-PTK) with accelerated corneal collagen cross linking (ACXL) in Keratoconus.

时间窗: 12 Months

次要结局

  • Visual outcome, astigmatic changes, changes in corneal clarity will be assessed and intra-operative and post-operative complications shall be observed.(12 Months)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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