Status:
COMPLETED
Transepithelial Corneal Collagen Cross-linking (CXL) in Treatment of Keratoconus
Lead Sponsor:
University Hospital of North Norway
Conditions:
Keratoconus
Eligibility:
All Genders
18-40 years
Phase:
PHASE2
Brief Summary
Transepithelial CXL (performed without epithelial removal) seem to have similar clinical effect on keratoconic eyes compared to the standard CXL (which includes epithelial removal). The current study ...
Detailed Description
CXL appears to hinder the development of keratoconus by strengthening the cross-bindings in the corneal stroma with a resultant increase in corneal biomechanical strength of up to 300%. The method was...
Eligibility Criteria
Inclusion
- Documented keratoconus progression in both eyes during the last 12 months before the treatment - decrease in best spectacle-corrected visual acuity (BSCVA) and/or increase in cornea curvature or asymmetry
- Corneal thickness ≥400μm at the thinnest point
- Age range from 18 to 40
- Amsler-Krumeich classification graded stage I to III
Exclusion
- Corneal thickness \<400μm at the thinnest point
- History of viral keratitis
- Severe dry eye
- Concurrent corneal infections
- Previous ocular surgery
- Hard contact lens wear for ≤4 weeks before baseline examination
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01181219
Start Date
July 1 2010
End Date
December 1 2014
Last Update
December 12 2014
Active Locations (1)
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1
University Hospital North Norway
Tromsø, Troms, Norway, 9000