Brief Title
Transepithelial Corneal Collagen Crosslinking in Eyes With Progressive Keratoconus
Official Title
Evaluation of Efficiency and Security of Transepithelial Corneal Collagen Crosslinking With Oxygen to Treat Progressive Keratoconus.
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.
Study Type
Interventional
Primary Outcome
Efficacy of the transepithelial crosslinking method
Secondary Outcome
Security of the transepithelial crosslinking
Condition
Keratoconus
Intervention
A crosslinking with oxygen treatment
Study Arms / Comparison Groups
Patient with progressive keratoconus
Description: Patient with progressive keratoconus will be included after providing their consent. The intervention administrated is a cross-linking with oxygen treatment
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
34
Start Date
December 21, 2017
Completion Date
June 2019
Primary Completion Date
September 2018
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
François Malecaze, MD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT03584243
Organization ID
RC31/17/0338
Secondary IDs
2017-A02661-52
Responsible Party
Sponsor
Study Sponsor
University Hospital, Toulouse
Study Sponsor
François Malecaze, MD, Principal Investigator, University Hospital, Toulouse
Verification Date
July 2018