Informations générales (source: ClinicalTrials.gov)

NCT03429569 Statut inconnu
Comparison in Confocal Microscopy and Optical Coherence Tomography of Postoperative Morphological Changes of Keratoconus Treated by Cross-linking of Collagen in Accelerated Procedure and in Iontophoresis Procedure (CLACICONE)
Interventional
  • Kératocône
Phase 4
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
août 2015
juin 2018
29 juin 2024
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.
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Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU Clermont-Ferrand - 63003 - Clermont-Ferrand - France Patrick LACARIN En recrutement Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

- 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%


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)