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

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Terminated
CT.gov ID
NCT01868620
Collaborator
Sooft Italia (Industry), Centre de Référence National du Kératocône (Other)
28
Enrollment
1
Location
2
Arms
46
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Iontophoretic CXL
  • Device: Standard CXL
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Non-inferiority Trial of Iontophoretic Corneal Collagen Crosslinking (CXL) Compared to Standard Corneal Collagen Crosslinking in Progressive Keratoconus.
Actual Study Start Date :
May 1, 2013
Actual Primary Completion Date :
Jun 1, 2016
Actual Study Completion Date :
Mar 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. The main outcome parameter is the non-inferiority of iontophoretic CXL compared to standard CXL in progressive keratoconus [Outcome measure is assessed at 1 year.]

    Measuring maximum keratometry (K-max) derived from computerized videokeratography.

Secondary Outcome Measures

  1. Comparison of minimum keratometry [3 months]

    Measure assessed by tomographic measurement.

Other Outcome Measures

  1. Comparison of mean keratometry [At 1 year]

    Tomographic measurement.

  2. Comparison of postoperative pain and complications during the follow up [Outcome measure is assessed at 1 year and at 3 months]

  3. Comparison of visual acuity [Outcome measure is assessed at 1 year and at 3 months]

  4. Intraoperative comparison of corneal concentration of riboflavin [Outcome measure is assessed at 1 year and at 3 months]

  5. Comparison of depth of treatment [Outcome measure is assessed at 1 year and at 3 months]

    By tomographic measurement

  6. Comparison of biomechanical parameters [Outcome measure is assessed at 1 year and at 3 months]

    By ORA (Ocular Response Analyzer)

  7. Comparison of corneal thickness [Outcome measure is assessed at 1 year and at 3 months for the tomographic measurement.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Toulouse Toulouse Midi-Pyrenees France 31059

Sponsors and Collaborators

  • University Hospital, Toulouse
  • Sooft Italia
  • Centre de Référence National du Kératocône

Investigators

  • Principal Investigator: François MALECAZE, MD, PhD,

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01868620
Other Study ID Numbers:
  • 13 030 03
  • HAO
First Posted:
Jun 4, 2013
Last Update Posted:
Jul 16, 2019
Last Verified:
Jul 1, 2019
Keywords provided by University Hospital, Toulouse
Progressive keratoconus
standard CXL
iontophoretic CXL
keratometry
Additional relevant MeSH terms:
Keratoconus

Study Results

No Results Posted as of Jul 16, 2019