Transepithelial Corneal Collagen Crosslinking in Eyes With Progressive Keratoconus

NCT03584243 | Unknown

• 2 other identifiers: RC31/17/03382017-A02661-52
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Keratoconus

Keywords

collagen crosslinking; transepithelial crosslinking

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Security of the transepithelial crosslinking

  One year

• Security of the transepithelial crosslinking

  One year

• Incidence and security of the transepithelial crosslinking

  One year

• Incidence and security of the transepithelial crosslinking

  One year

Study Arms (1)

Patient with progressive keratoconus

EXPERIMENTAL

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

Interventions

A crosslinking with oxygen treatment PROCEDURE

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.

Patient with progressive keratoconus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, 31052, France

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• François Malecaze, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This experimental study is a prospective, one-center city and non-comparative study. Patient with progressive keratoconus will be included after providing their consent. The intervention of the study is to perform transepithelial crosslinking with oxygen Outcomes will be evaluated from pretreatment baseline of the patient.

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: July 12, 2018
• Study Start: December 21, 2017
• Primary Completion: September 1, 2018
• Study Completion: June 1, 2019
• Last Updated: July 12, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)