跳至主要内容
临床试验/CTRI/2025/10/095984
CTRI/2025/10/095984尚未招募不适用

Evaluation of corneal biomechanical alterations in keratoconus and pellucid marginal degeneration patients after RGP and ROSE K contact lens wear

Sankara Eye Hospital1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年10月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
46
试验地点
1
主要终点
The corneal stiffness and deformation amplitude changes after 3 months and 6 months of Rose K contact lens wear in keratoconus and pellucid marginal degeneration patients.

研究概览

简要总结

To evaluate the corneal biomechanical alterations in patients with keratoconus and pellucid marginal degeneration following the use of RGP and Rose K contact lenses. Data comparision would be taken with the CORVIS ST parameters like

CBI

SP A1

DA RATIO

IR

To monitor the changes in corneal stiffness and deformation amplitude after a 3 and 6 months of RGP and Rose K CL wear in both patient group.

To assess the difference in post lens wear changes in the corneal biomechanical properties between RGP and Rose K lenses.

To understand which lenses are the better option to maintain corneal integrity

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • KCN and PMD patients Eligible for RGP and Rose K CL.

排除标准

  • C3R surgery Previous RGP and Rose K CL wear Corneal scaring Infectious or inflammatory ocular diseases Corneal graft surgery.

结局指标

主要结局

The corneal stiffness and deformation amplitude changes after 3 months and 6 months of Rose K contact lens wear in keratoconus and pellucid marginal degeneration patients.

时间窗: Baseline | 3 months | 6 months

次要结局

  • The difference in post lens wear changes in the corneal biomechanical properties between RGP and Rose K lenses.(Baseline)

研究者

申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Vandana Kamath

Sankara Eye Hospital

研究点 (1)

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