Status:
TERMINATED
Non-inferiority Trial of Iontophoretic Corneal Collagen Crosslinking (CXL) Compared to Standard Corneal Collagen Crosslinking in Progressive Keratoconus.
Lead Sponsor:
University Hospital, Toulouse
Collaborating Sponsors:
Sooft Italia
Centre de Référence National du Kératocône
Conditions:
Progressive Keratoconus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary purpose of the protocol is to compare the current standard CXL with iontophoretic CXL to provide evidence in relation to the efficacy and safety in progressive keratoconus. Corneal collag...
Detailed Description
Keratoconus is a common bilateral progressive corneal ecstatic disease causing visual impairment by inducing irregular astigmatism and corneal opacities. This disorder typically begins during teenage ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old
- Corneal thickness ≥ 400 µm
- Progressive stage 1 to 3 keratoconus (Krumeich classification)
Exclusion
- Corneal thickness \< 400µm
- Stage 4 keratoconus (Krumeich classification)
- Concomitant corneal disease
- History of corneal surgery
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01868620
Start Date
May 1 2013
End Date
March 1 2017
Last Update
July 16 2019
Active Locations (1)
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1
University Hospital Toulouse
Toulouse, Midi-Pyrenees, France, 31059