Cross-Linking ACcéléré Iontophorèse Confocal kératocONE (CLACICONE)

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

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.

Study Overview

• Status: Unknown
• Conditions: Keratoconus
• Intervention / Treatment: Drug: Cross linking

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Patrick LACARIN; Phone Number: 04 73 75 11 95; Email: placarin@chu-clermontefrrand.fr

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • CHU Clermont-Ferrand
    • Principal Investigator: Frédéric CHIAMBARETTA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%

Exclusion Criteria:

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: accelerated conventional technique; Pachymetry greater than 400μm Topographic criteria for keratoconus evolution: Variation over a 6-month period of the following changes: 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 meridian and the most arched and the least arched (Kmax-Kmin) greater than or equal to 0.75D And / or a decrease in the central thickness greater than or equal to 2% Criteria of non-inclusion Age under 18 Ectasies post LASIK Pregnant women breastfeeding Major corneal opacities Absence of consent to participation in the study No affiliation to Social Security or State Medical Aid (AME) or Universal Medical Coverage (CMU)	Drug: Cross linking; Accelerated cross-linking procedure: (Total duration: 40 minutes)
Sham Comparator: iontophoresis; Pachymetry greater than 400μm Topographic criteria for keratoconus evolution: Variation over a 6-month period of the following changes: 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 meridian and the most arched and the least arched (Kmax-Kmin) greater than or equal to 0.75D And / or a decrease in the central thickness greater than or equal to 2% Criteria of non-inclusion Age under 18 Ectasies post LASIK Pregnant women breastfeeding Major corneal opacities Absence of consent to participation in the study No affiliation to Social Security or State Medical Aid (AME) or Universal Medical Coverage (CMU)	Drug: Cross linking; Accelerated cross-linking procedure: (Total duration: 40 minutes)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
depth of the demarcation line	depth of the demarcation line measured by confocal microscopy	at one month

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Frederic CHIAMBARETTA, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2015
• Primary Completion (Actual): February 1, 2017
• Study Completion (Anticipated): June 30, 2018

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (Actual): February 12, 2018

Study Record Updates

• Last Update Posted (Actual): February 13, 2018
• Last Update Submitted That Met QC Criteria: February 12, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Cross-linking; Keratoconus; Confocal microscopy; Postoperative morphological; Iotonphoresis
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus
• Other Study ID Numbers: CHU-369; 2015-A00242-47 (Other Identifier: 2015-A00242-47)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No