The changes in the Corneal endothelial layer of the eyes of patients with keratoconus who are currently using scleral lens
Not Applicable
- Conditions
- Health Condition 1: H186- Keratoconus
- Registration Number
- CTRI/2024/04/066331
- Lead Sponsor
- Medical Research Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
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
Exclusion Criteria
Active inflammatory or infective disease. having fuchs dystrophy, ACUTE hydrops or ocular trauma or surgery
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method There will be changes as per the sample size <br/ ><br>calculation to determine the effect of intervention <br/ ><br>that can be INCREASE OR decrease in the <br/ ><br>corneal endothelial INCLUDING COEFFFICIENT <br/ ><br>OF VARIATION, HEX SCORE AND CELL <br/ ><br>COUNT OF CORNEAL ENDOTHELIALTimepoint: At 6 months and then at 1 year and 3 years the data will be recorded
- Secondary Outcome Measures
Name Time Method secondary outcome is the same as my primary <br/ ><br>outcome which is an event, variable, or <br/ ><br>experience as the primary outcome, but <br/ ><br>measured at time-points other than those of <br/ ><br>primary interest which is now 1 year There will <br/ ><br>be changes-INCREASE OR DECREASE in the <br/ ><br>corneal endothelial INCLUDING COEFFFICIENT <br/ ><br>OF VARIATION, HEX SCORE AND CELL <br/ ><br>COUNT OF CORNEAL ENDOTHELIALIN LONG <br/ ><br>TERM WEARERSTimepoint: WILL BE SEEN at baseline then AFTER 1 <br/ ><br>YEARS AND 5 YEARS AS WE