Non-inferiority Trial of Iontophoretic Corneal Collagen Crosslinking (CXL) Compared to Standard Corneal Collagen Crosslinking in Progressive Keratoconus. (IONTO-CXL)

July 12, 2019 updated by: University Hospital, Toulouse

The primary purpose of the protocol is to compare the current standard CXL with iontophoretic CXL to provide evidence in relation to the efficacy and safety in progressive keratoconus.

Corneal collagen crosslinking (CXL) is the first surgical procedure that appears to halt the progression of keratoconus. In the current standard CXL, the central corneal epithelium must be debrided to efficiently permeate the corneal stroma with riboflavin. The epithelium debridement can cause severe pain, infection and stromal haze. The study hypothesis is that iontophorese CXL is as effective as standard CXL to stabilize a progressive keratoconus.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Keratoconus is a common bilateral progressive corneal ecstatic disease causing visual impairment by inducing irregular astigmatism and corneal opacities. This disorder typically begins during teenage years, progresses until the age of 30 to 40 years and, in severe forms, may need a corneal transplantation. CXL has changed the natural evolution of keratoconus. It creates links between collagen fibrils in order to rigidify the corneal stroma and slow down the progression of keratoconus. The corneal stroma is soaked with a riboflavin solution before being exposed to ultraviolet-A radiation.

In the current standard CXL, the central corneal epithelium must be debrided to allow the penetration of riboflavin into the cornea with a risk of side effects, such as pain for the first two post-operative days, temporary loss of visual acuity during the first three months, and serious complications such as infection and stromal opacity due to corneal scarring.

Iontophoresis is a non invasive technique in which a weak electric current is used to enhance the penetration of riboflavin into the cornea. The iontophoresis technique could allow intrastromal riboflavin diffusion, while keeping the corneal epithelium on, combining the efficiency of the standard procedure without the side effects of epithelial debridement.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Midi-Pyrenees
      • Toulouse, Midi-Pyrenees, France, 31059
        • University Hospital Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years old
  • Corneal thickness ≥ 400 µm
  • Progressive stage 1 to 3 keratoconus (Krumeich classification)

Exclusion Criteria:

  • Corneal thickness < 400µm
  • Stage 4 keratoconus (Krumeich classification)
  • Concomitant corneal disease
  • History of corneal surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Iontophoretic CXL
The iontophoretic CXL involves a constant current source and two electrodes. The main electrode is a circular cup, with a surrounding annular suction ring to affix the device on the cornea during the procedure. The electrode itself is a stainless steel grid, placed into the cup at a minimal distance from the cornea. The reservoir is filled with riboflavin solution. The generator applies a constant current of 1mA for a preset period of 5 min. After the riboflavin administration by iontophoresis, the cornea is irradiated by a UVA light for 3mW/cm2 during 30 minutes.
Device: Iontophoretic CXL
Active Comparator: Standard CXL
In the standard CXL, the epithelium is mechanically removed. Then, a solution of riboflavin is instilled each minute for 30 minutes. Corneas are irradiated by a UVA light for 3mW/cm2 during 30 minutes.
Device: Standard CXL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The main outcome parameter is the non-inferiority of iontophoretic CXL compared to standard CXL in progressive keratoconus
Time Frame: Outcome measure is assessed at 1 year.
Measuring maximum keratometry (K-max) derived from computerized videokeratography.
Outcome measure is assessed at 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of minimum keratometry
Time Frame: 3 months
Measure assessed by tomographic measurement.
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of mean keratometry
Time Frame: At 1 year
Tomographic measurement.
At 1 year
Comparison of postoperative pain and complications during the follow up
Time Frame: Outcome measure is assessed at 1 year and at 3 months
Outcome measure is assessed at 1 year and at 3 months
Comparison of visual acuity
Time Frame: Outcome measure is assessed at 1 year and at 3 months
Outcome measure is assessed at 1 year and at 3 months
Intraoperative comparison of corneal concentration of riboflavin
Time Frame: Outcome measure is assessed at 1 year and at 3 months
Outcome measure is assessed at 1 year and at 3 months
Comparison of depth of treatment
Time Frame: Outcome measure is assessed at 1 year and at 3 months
By tomographic measurement
Outcome measure is assessed at 1 year and at 3 months
Comparison of biomechanical parameters
Time Frame: Outcome measure is assessed at 1 year and at 3 months
By ORA (Ocular Response Analyzer)
Outcome measure is assessed at 1 year and at 3 months
Comparison of corneal thickness
Time Frame: Outcome measure is assessed at 1 year and at 3 months for the tomographic measurement.
Outcome measure is assessed at 1 year and at 3 months for the tomographic measurement.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Collaborators

Centre de Référence National du Kératocône
Sooft Italia

Investigators

  • Principal Investigator: François MALECAZE, MD, PhD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2013

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

May 29, 2013

First Submitted That Met QC Criteria

May 30, 2013

First Posted (Estimate)

June 4, 2013

Study Record Updates

Last Update Posted (Actual)

July 16, 2019

Last Update Submitted That Met QC Criteria

July 12, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13 030 03
  • HAO (Other Identifier: University Hospital of Toulouse)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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