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A clinical study to compare the safety and effectiveness of accelerated CXL(a corneal strengthening procedure) done with assistance of SMILE lenticule versus contact lens in patients of keratoconus with thin cornea

A CLINICAL STUDY TO EVALUATE THE VISUAL, BIOMECHANICAL AND ANATOMICAL OUTCOMES OF SMILE LENTICULE ASSISTED ACCELERATED CORNEAL COLLAGEN CROSS LINKING VERSUS CONTACT LENS ASSISTED ACCELERATED CORNEAL COLLAGEN CROSS LINKING IN PATIENTS OF KERATOCONUS WITH THIN CORNEA.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/01/049079
Enrollment
30
Registered
2023-01-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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

Control Intervention1: ACCELERATED CORNEAL COLLAGEN CROSS LINKING(aCXL) WITH OVERLAYING CONTACT LENS: Contact lens assisted aCXL can be done in keratoconus patients with thin cornea. Contact lens inc

Sponsors

Kalyani
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with progressive keratoconus. Progression of keratoconus is defined as increase in steepest keratometry (Kmax) by >0.5 Diopter(D) or increase in flattest Keratometry (Kmin) by >1D or increase in mean keratometry (Kmean) by >0.5D or increase in manifest spherical equivalent >0.5D during 6 month or decrease in central corneal thickness by >2%. 2.Age â?? 16-40 years 3.Corneal thickness of less than 425 micron and more than 350 micron before epithelial debridement 4.Patient giving consent for the procedure and follow up.

Exclusion criteria

Exclusion criteria: 1.Post refractive surgery cornea 2.Active intraocular infection, inflammation, allergy. 3.Corneal scarring 4.Pterygium 5.Pregnancy, Lactation 6.Post ocular trauma 7.Age less than 16 years 8.CCT less than 350 micron

Design outcomes

Primary

MeasureTime frame
(A) Safety - by assessing changes in corneal endothelium (B) Efficacy- stabilization of Km, change in Kmax Timepoint: Day7, 1month, 3month, 6month, 1year—

Secondary

MeasureTime frame
(A)Improvement in BCVA (B)Change in refraction (C)Improvement in biomechanical strength Timepoint: Day1,3and7, 1month, 3month, 6month, 1year—

Countries

India

Contacts

Public ContactDr Mahipal S Sachdev

Centre for Sight

drmahipal@gmail.com7903605778

Outcome results

None listed

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