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The changes in the Corneal endothelial layer of the eyes of patients with keratoconus who are currently using scleral lens

Corneal endothelial changes in scleral lens wearers in keratoconic eyes. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/04/066331
Enrollment
100
Registered
2024-04-25
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H186- Keratoconus

Interventions

Intervention1: Nil: NIL

Sponsors

Medical Research Foundation
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: Active inflammatory or infective disease. having fuchs dystrophy, ACUTE hydrops or ocular trauma or surgery

Design outcomes

Primary

MeasureTime frame
There will be changes as per the sample size calculation to determine the effect of intervention that can be INCREASE OR decrease in the corneal endothelial INCLUDING COEFFFICIENT OF VARIATION, HEX SCORE AND CELL COUNT OF CORNEAL ENDOTHELIALTimepoint: At 6 months and then at 1 year and 3 years the data will be recorded

Secondary

MeasureTime frame
secondary outcome is the same as my primary outcome which is an event, variable, or experience as the primary outcome, but measured at time-points other than those of primary interest which is now 1 year There will be changes-INCREASE OR DECREASE in the corneal endothelial INCLUDING COEFFFICIENT OF VARIATION, HEX SCORE AND CELL COUNT OF CORNEAL ENDOTHELIALIN LONG TERM WEARERSTimepoint: WILL BE SEEN at baseline then AFTER 1 YEARS AND 5 YEARS AS WELL

Countries

India

Contacts

Public ContactShruti Dagar

The Sankara Nethralaya Academy

shrutidagar54@gmail.com8585925728

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026