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

Primary Purpose

Keratoconus

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
De-epithelization and therapeutic photokeratectomy
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring keratoconus, photokeratectomy, de-epithelization

Eligibility Criteria

15 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondation Ophtalmologique Adolphe de Rothschild

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Evolutive keratoconus

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 3, 2016
Last Updated
June 7, 2019
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
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1. Study Identification

Unique Protocol Identification Number
NCT02857881
Brief Title
Corneal De-epithelization Associated With a Therapeutic Photokeratectomy in Patients With Evolutive Keratoconus
Acronym
KERADES
Official Title
Effect of Simple Corneal De-epithelization Associated With a Therapeutic Photokeratectomy in Patients With Evolutive Keratoconus
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
Difficulty of inclusion of patients, impossible to reach the expected number
Study Start Date
October 13, 2015 (Actual)
Primary Completion Date
February 7, 2019 (Actual)
Study Completion Date
February 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
keratoconus, photokeratectomy, de-epithelization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evolutive keratoconus
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
De-epithelization and therapeutic photokeratectomy
Primary Outcome Measure Information:
Title
Evolutivity of keratoconus (Proportion of patients who lost the evolutivity of their keratoconus)
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Fondation Ophtalmologique Adolphe de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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