Cross-Linking ACcéléré Iontophorèse Confocal kératocONE
NCT03429569 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2018-02-13
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 technique or iontophoresis). The primary endpoint will be the depth of the demarcation line measured by confocal microscopy and OCT at 1 month. This line represents the limit depth between treated and untreated stroma.
Conditions
- Keratoconus
Interventions
- DRUG
-
Cross linking
Accelerated cross-linking procedure: (Total duration: 40 minutes)
Sponsors & Collaborators
-
University Hospital, Clermont-Ferrand
lead OTHER
Principal Investigators
-
Frédéric CHIAMBARETTA · University Hospital, Clermont-Ferrand
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-08-12
- Primary Completion
- 2017-02-01
- Completion
- 2018-06-30
Countries
- France
Study Locations
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