Status:
UNKNOWN
Cross-Linking ACcéléré Iontophorèse Confocal kératocONE
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Keratoconus
Eligibility:
All Genders
18-40 years
Phase:
PHASE4
Brief Summary
A monocentric, parallel-arm, prospective, randomized therapeutic trial that compares the efficacy of two curative keratoconus treatment techniques by cross-linking collagen (accelerated conventional t...
Detailed Description
A two-arm, parallel, open-label, prospective, randomized therapeutic trial comparing two management strategies. The goal is to describe and compare, thanks to in vivo confocal microscopy and optical c...
Eligibility Criteria
Inclusion
- Pachymetry greater than 400μm
- Topographic criteria for keratoconus evolution:
- Variation over a period of 6 months of the following parameters:
- An increase equal to or greater than 1D of maximum keratometry (Kmax) And / or an increase in mean keratometry (Kmean) greater than or equal to 0.75D And / or an increase in the difference between the most arched and the least arched meridian (Kmax-Kmin) greater than or equal to 0.75D And / or a decrease in corneal central thickness greater than or equal to 2%
Exclusion
- Ectasies post LASIK Pregnant women breastfeeding Major corneal opacities Absence of consent to participate in the study No affiliation to social security or State Medical Aid (AME) or Universal Medical Coverage (CMU)
Key Trial Info
Start Date :
August 12 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03429569
Start Date
August 12 2015
End Date
June 30 2018
Last Update
February 13 2018
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003