Cross-Linking ACcéléré Iontophorèse Confocal kératocONE

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-12

Study Completion Date

2018-06-30

Brief Summary

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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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Detailed Description

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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

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Keratoconus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

No masking

Study Groups

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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)

Group Type SHAM_COMPARATOR

Cross linking

Intervention Type DRUG

Accelerated cross-linking procedure: (Total duration: 40 minutes)

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)

Group Type SHAM_COMPARATOR

Cross linking

Intervention Type DRUG

Accelerated cross-linking procedure: (Total duration: 40 minutes)

Interventions

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Cross linking

Accelerated cross-linking procedure: (Total duration: 40 minutes)

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No