Transepithelial Corneal Collagen Crosslinking in Eyes With Progressive Keratoconus

NCT ID: NCT03584243

Last Updated: 2018-07-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-21
• Study Completion Date: 2019-06-30

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.

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.

Conditions

Keratoconus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

A crosslinking with oxygen treatment

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François Malecaze, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

University Hospital Toulouse

Toulouse, , France

Countries

France

Other Identifiers

2017-A02661-52

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/17/0338

Identifier Type: -

Identifier Source: org_study_id