NCT03429569

Cross-Linking ACcéléré Iontophorèse Confocal kératocONE

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

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 coherence tomography (OCT), the structural modifications observed postoperatively on evolutive keratoconus treated by cross-linking of collagen in accelerated procedure and iontophoresis. The study will be monocentric and will take place in the ophthalmology department of Clermont-Ferrand University Hospital. Patients will be recruited through consultation dedicated to keratoconus (The ophthalmology department of Clermont-Ferrand is one of the 9 French centers of expertise for this pathology). Inclusion will be offered to all patients over 18 years old who meet the scalability criteria and who will benefit from a cross-linking procedure. Blind randomization will be performed between iontophoresis and accelerated procedure. The dates of the visits will be fixed, with a preoperative evaluation, and a follow-up follow-up on 6 months with controls at 1 month, 3 months and 6 months. Confocal microscopy imaging and OCT will be performed during the preoperative visit and during visits at 1 month, 3 months and 6 months.

Conditions

• Keratoconus

Interventions

Type	Name	Description
DRUG	Cross linking	Accelerated cross-linking procedure: (Total duration: 40 minutes)

Timeline

• Start date: 2015-08-12
• Primary completion: 2017-02-01
• Completion: 2018-06-30
• First posted: 2018-02-12
• Last updated: 2018-02-13

Locations

1 site across 1 country: France