Brief Title
Corneal De-epithelization Associated With a Therapeutic Photokeratectomy in Patients With Evolutive Keratoconus
Official Title
Effect of Simple Corneal De-epithelization Associated With a Therapeutic Photokeratectomy in Patients With Evolutive Keratoconus
Brief Summary
Keratoconus is a symmetrical, bilateral, non-inflammatory, idiopathic corneal pathology,
characterized by a progressive corneal thinning. This disease leads to a bombing of the
cornea, inducing a strong corneal astigmatism, responsible for a loss of visual acuity
sometimes very important, non-correctable by lens of glasses. Collagen Cross-Linking (CXL)
and simple corneal de-epithelization are two common surgical technics aiming to slow the
progression of this pathology. They consist in rigidifying the corneal structure in order to
stabilize its deformation progression. Even though these technics are commonly performed,
none of these strategies has proven their efficiency. The effects of CXL can be due to the
superficial scarring reaction as well as the effects of corneal remodeling induced by the
de-epithelization phase during a CXL procedure, and not due to the covalent links between
collagen and fibrils, formed by the biochemical reaction resulting from the UV-A exposition
in the presence of Riboflavine De-epithelization may be an equally effective treatment, when
compared to CXL, but without long term secondary effects. Its association with a therapeutic
photokeratectomy (PKT, surgical technic used to regulate the corneal surface, and eliminate
its opacities in order to recuperate the transparency of the cornea) will aim to improve the
regularity of the anterior corneal surface, thus allowing a better epithelial attachment
(adhesion) and may allow a stromal inflammatory reaction, favorable to the improvement of
corneal biomechanics. PKT is a reliable technic; however it has not yet proven its efficiency
in the treatment of keratoconus.
The purpose of this study is to describe the effects of de-epithelization associated with a
therapeutic photokeratectomy in patients with evolutive keratoconus, by showing the
proportion of patients who lost the evolutivity of their keratoconus, after 6 months and 1
year, after an intervention of de-epithelization associated with therapeutic
photokeratectomy.
Study Type
Interventional
Primary Outcome
Evolutivity of keratoconus (Proportion of patients who lost the evolutivity of their keratoconus)
Condition
Keratoconus
Intervention
De-epithelization and therapeutic photokeratectomy
Study Arms / Comparison Groups
Evolutive keratoconus
Description:
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
20
Start Date
October 13, 2015
Completion Date
February 7, 2019
Primary Completion Date
February 7, 2019
Eligibility Criteria
Inclusion Criteria:
- Patients aged from 15 to 45 years old
- Patients with an evolutive keratoconus
- Planned intervention (de-epithelization and photokeratectomy)
Exclusion Criteria:
- Contra-indication to de-epithelization (active scarring corneal lesion)
- Pregnant women and breastfeeding
- Absence of the written consent to participate in the trial
Gender
All
Ages
15 Years - 45 Years
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT02857881
Organization ID
ASD_2014-12
Responsible Party
Sponsor
Study Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Study Sponsor
, ,
Verification Date
June 2019