Corneal De-epithelization Associated With a Therapeutic Photokeratectomy in Patients With Evolutive Keratoconus

Keratoconus Clinical Trial

— KERADES  

Official title:

Effect of Simple Corneal De-epithelization Associated With a Therapeutic Photokeratectomy in Patients With Evolutive Keratoconus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02857881
• Other study ID #: ASD_2014-12
• Status: Terminated
• Phase: N/A
• Start date: October 13, 2015
• Est. completion date: February 7, 2019

Study information

• Verified date: June 2019
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: February 7, 2019
• Est. primary completion date: February 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Keratoconus

Intervention

Procedure:
• De-epithelization and therapeutic photokeratectomy

Locations

Country	Name	City	State
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolutivity of keratoconus (Proportion of patients who lost the evolutivity of their keratoconus)	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	6 months