跳至主要内容
临床试验/CTRI/2024/04/066331
CTRI/2024/04/066331进行中(未招募)不适用

Corneal endothelial changes in scleral lens wearers in keratoconic eyes.

Medical Research Foundation1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年5月22日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
1
主要终点
There will be changes as per the sample size

研究概览

简要总结

Aim is to evaluate the corneal endothelial changes in scleral lens wearers in keratoconic eyes. It is a retrospective study where the data in hospital EMR will be used from 5 years back to find the difference in the endothelial with specular microscopy.

This might indicate that scleral lens are useful and may have  an effect on endothelial layer by protecting it or the cell count may decrease by wearing contact lens.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Participants directly fitted with scleral lens in at least one eye without any previous history of using any other modality lenses other than scleral lenses.
  • Must have had measurements taken before and after initiation of SL wear.

排除标准

  • Active inflammatory or infective disease.
  • having fuchs dystrophy, ACUTE hydrops or ocular trauma or surgery.

结局指标

主要结局

There will be changes as per the sample size

时间窗: At 6 months and then at 1 year and 3 years the data will be recorded

calculation to determine the effect of intervention

时间窗: At 6 months and then at 1 year and 3 years the data will be recorded

that can be INCREASE OR decrease in the

时间窗: At 6 months and then at 1 year and 3 years the data will be recorded

corneal endothelial INCLUDING COEFFFICIENT

时间窗: At 6 months and then at 1 year and 3 years the data will be recorded

OF VARIATION, HEX SCORE AND CELL

时间窗: At 6 months and then at 1 year and 3 years the data will be recorded

COUNT OF CORNEAL ENDOTHELIAL

时间窗: At 6 months and then at 1 year and 3 years the data will be recorded

次要结局

  • secondary outcome is the same as my primary(outcome which is an event, variable, or)

研究者

申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Shruti Dagar

The Sankara Nethralaya Academy

研究点 (1)

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