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A study to compare two different methods of strengthening the cornea in a disease called Keratoconus in children

A Comaparitive study of Standard versus Accelerated protocols of Collagen cross linking in the treatment of Pediatric Keratoconus-A randomised controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050925
Enrollment
52
Registered
2023-03-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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: Corneal collagen cross-linking: Study Participants with keratoconus are subjected to two different protocols of corneal collagen cross-linking the safety of which has been established i

Sponsors

Bangalore Medical college and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)All patients in the above age group with clinically and topgraphically diagnosed keratoconus

Exclusion criteria

Exclusion criteria: 1) Patients not giving informed consent 2) Corneal thinnest local less than 400 micron 3) Post lasik ectasia 4) Traumatic ectasia 5) Previous ocular surgery

Design outcomes

Primary

MeasureTime frame
1)Difference in Kmax at the end of three years in the two protocols 2) Difference in corneal thickness measurements at the end of three years in the two protocolsTimepoint: At baseline followed by 1, 3,6,12,18,24,30 and 36 months

Secondary

MeasureTime frame
1)Visual outcome in terms of Logmar 2) Endothelial cell density changes in the two protocolsTimepoint: 3 years

Countries

India

Contacts

Public ContactSwetha Mallagundla

MINTO OPHTHALMIC HOSPITAL,BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE

drmswetha@gmail.com7348959926

Outcome results

None listed

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