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To study the corneal stiffness map in Normal eyes, Keratoconic eyes and patients with Diabetes

Evaluation of Corneal Biomechanics: Stress-Strain Index (SSI) Mapping Using Corvis ST in Normal, Diabetic, and Keratoconic Patients - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/11/097572
Enrollment
470
Registered
2025-11-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

None listed

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil Intervention4: Nil: Nil

Sponsors

Medical Research Foundation
Lead Sponsor
DrDaniela Oehring
Collaborator
DrElsheikh Ahmed
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Normal Group Age 20 to 70 years Best corrected visual acuity of 20/25 or better Normal corneal topography and tomography Refractive error within plus or minus 5.0 D spherical and plus or minus 3.0 D cylindrical Keratoconus Group Age 18 to 45 years Clinical diagnosis of keratoconus KC staging according to ABCD grading system No previous corneal surgery including CXL Diabetic Group Age 30 to 70 years Type 1 or Type 2 diabetes mellitus diagnosis Diabetes duration equal to or greater than 5 years Recent HbA1c value within 3 months Stable glycemic control for equal to or greater than 3 months

Exclusion criteria

Exclusion criteria: All Groups Previous ocular surgery (including CXL, PRK, LASIK, cataract surgery) Active ocular infection or inflammation Corneal scarring or opacity Glaucoma or ocular hypertension (IOP greater than 21 mmHg) Pregnancy or breastfeeding Contact lens wear (soft lenses washout 2 weeks, RGP washout 4 weeks) Systemic medications affecting cornea (e.g., amiodarone, isotretinoin) Connective tissue disorders (e.g., Marfan syndrome, Ehlers-Danlos)

Design outcomes

Primary

MeasureTime frame
Global SSI differences and regional SSI map metricsTimepoint: Baseline, 3, 6, 9, and 12 months for the Longitudinal Sub Group—

Secondary

MeasureTime frame
Diagnostic performance (AUC, sensitivity, specificity), age SSI correlationTimepoint:—

Countries

India

Contacts

Public ContactSapna Yadav

Medical Research Foundation

drpp@snmail.org9176681588

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026