Transepithelial Corneal Collagen Crosslinking in Eyes With Progressive Keratoconus (TE-CXL)

Evaluation of Efficiency and Security of Transepithelial Corneal Collagen Crosslinking With Oxygen to Treat Progressive Keratoconus.

Keratoconus is a corneal ectatic disease responsible for a loss of visual acuity when the steepening increases. Corneal collagen crosslinking (CXL) is a procedure that appears to halt or slow down the progression and avoid the visual impairment. However, such a technique requires the epithelium debridement, wich can be responsible for severs complications.

This study evaluate the safety and efficacy of transepithelial corneal crosslinking with oxygen to halt or slow down the progression of keratoconus. Such a procedure avoids the epithelium debridement and the related complications.

Study Overview

• Status: Unknown
• Conditions: Keratoconus
• Intervention / Treatment: Procedure: A crosslinking with oxygen treatment

Detailed Description

Keratoconus is a common bilateral progressive corneal ectatic disease causing visual impairment by inducing irregular astigmatism and corneal opacities. This disorder typically begins during teenage years. Patients with severe forms may need a corneal transplantation. The CXL procedure, described in 1998, allows to halt or to slow down the disease progression and may avoid other surgeries, e.g. transplantation. This technique creates links between collagen fibrils in order to rigidify the corneal stroma. The corneal stroma is soaked with a riboflavin solution (vitamin B2) before being exposed to ultraviolet-A (UVA) radiations. 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 infections and stromal opacity due to corneal scarring Transepithelial crosslinking is a non-invasive technique in which benzalkonium chloride is used to enhance the penetration of riboflavin into the cornea. To improve the reaction, a device provides oxygen to the corneal surface. The transepithelial technique could allow intrastromal riboflavin diffusion, while keeping the corneal epithelium on, conserving the efficiency of the standard procedure without the complications induced by epithelial debridement.

Patient with progressive keratoconus will be included and treated with the transepithelial procedure. The follow-up will last for one year. Every follow-up visit will evaluate the security of the procedure and its efficacy to stop or slow down the progression of the disease. Interrogatory and slit lamp examination will be performed to investigate the potential adverse effects of the procedure.

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31052
    • University Hospital Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be at least 18 years of age
• Provide written informed consent
• Diagnosis of progressive keratoconus
• Best corrected visual acuity between 0,05 and 1 decimal scale
• Willingness to follow all instructions and comply with schedule for follow-up visits.
• Social security insurance or equivalent.

Exclusion Criteria:

• Hypersensitivity to local treatment
• Corneal pachymetry < 400 μm
• Non progressive keratoconus
• Aphakic eye or eye with cataract implant without UV filter
• Concomitant corneal disease
• History of corneal surgery
• History of crosslinking treatment
• Pregnancy or lactation
• Juridical protection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patient with progressive keratoconus; Patient with progressive keratoconus will be included after providing their consent. The intervention administrated is a cross-linking with oxygen treatment

Procedure: A crosslinking with oxygen treatment; A supplemental oxygen system during the cross linking will be used to apply filtered, humidified oxygen across the surface of the eye through a mask. The oxygen flow will be turned on immediately prior to initiation of irradiation, and will continue through the irradiation period. The supplemental oxygen flow will be shut off following completion of the programmed irradiation time. All subjects will be evaluated at screening, day 3, and 1, 3, 6, 12 and 24 months after treatment. At the same time all the potential adverse effects will be relieved.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of the transepithelial crosslinking method	The non-comparative evaluation of the efficacy of crosslinking of transepithelial corneal collagen with oxygen in the stabilization of progressive keratoconus during 12 months of follow-up. - Change from pretreatment baseline : keratometry at one year.	One year
Efficacy of the transepithelial crosslinking method	The non-comparative evaluation of the efficacy of crosslinking of transepithelial corneal collagen with oxygen in the stabilization of progressive keratoconus during 12 months of follow-up. - Change from pretreatment in manifest refraction spherical equivalent at one year.	One year
Efficacy of the transepithelial crosslinking method	- Change from pretreatment baseline : best corrected/uncorrected visual acuity at one year	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Security of the transepithelial crosslinking	The non-comparative evaluation of the safety of crosslinking of transepithelial corneal collagen with oxygen in the stabilization of progressive keratoconus during 12 months of follow-up. - Change from pretreatment baseline : intraocular pressure at one year.	One year
Security of the transepithelial crosslinking	The non-comparative evaluation of the safety of crosslinking of transepithelial corneal collagen with oxygen in the stabilization of progressive keratoconus during 12 months of follow-up. - Change from baseline in endothelial cell count at one year.	One year
Incidence and security of the transepithelial crosslinking	- Incidence of treatment emergent ocular adverse events reported during the study.	One year
Incidence and security of the transepithelial crosslinking	- Percentage of eyes with loss in best corrected of three lines from pretreatment baseline.	One year

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: François Malecaze, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2017
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: July 10, 2018
• First Posted (Actual): July 12, 2018

Study Record Updates

• Last Update Posted (Actual): July 12, 2018
• Last Update Submitted That Met QC Criteria: July 10, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: collagen crosslinking; transepithelial crosslinking
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus
• Other Study ID Numbers: RC31/17/0338; 2017-A02661-52 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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