- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02857881
Corneal De-epithelization Associated With a Therapeutic Photokeratectomy in Patients With Evolutive Keratoconus (KERADES)
Effect of Simple Corneal De-epithelization Associated With a Therapeutic Photokeratectomy in Patients With Evolutive Keratoconus
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75019
- Fondation Ophtalmologique Adolphe de Rothschild
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Evolutive keratoconus
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evolutivity of keratoconus (Proportion of patients who lost the evolutivity of their keratoconus)
Time Frame: 6 months
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASD_2014-12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Keratoconus
-
The Cleveland ClinicUniversity of MarylandEnrolling by invitationKeratoconus | Keratoconus, Unstable | Keratoconus, StableUnited States
-
Eye Hospital Pristina KosovoActive, not recruitingKeratoconus | Keratoconus of Right Eye | Keratoconus, Unstable, Right EyeKosovo
-
Tianjin Eye HospitalRecruitingScansys, Pentacam, Keratoconus, Subclinical KeratoconusChina
-
Tianjin Eye HospitalActive, not recruitingScansys, Pentacam, Corvis ST, Keratoconus, Subclinical KeratoconusChina
-
Heba Allah Nashaat MohamedAssiut UniversityRecruitingKeratoconus, CollagenEgypt
-
Kent Wellish MDNot yet recruitingKeratoconus, Unstable
-
Kasr El Aini HospitalUnknownProgressive KeratoconusEgypt
-
Centre Hospitalier Régional Metz-ThionvilleCompletedProgressive Keratoconus
-
Glaukos CorporationCompletedProgressive KeratoconusUnited States
-
Tianjin Eye HospitalCompletedKeratoconus, StableChina
Clinical Trials on De-epithelization and therapeutic photokeratectomy
-
Chinese University of Hong KongCompletedType 2 Diabetes | Acceptance and Commitment Therapy | Diabetes DistressHong Kong
-
Universitaire Ziekenhuizen KU LeuvenKU Leuven; Stichting tegen KankerRecruitingSquamous Cell Carcinoma of Head and NeckBelgium
-
Santen Inc.CompletedAge-Related Macular DegenerationUnited States
-
University Hospital OstravaCompleted
-
M.D. Anderson Cancer CenterRecruitingPancreatic Ductal AdenocarcinomaUnited States
-
Santen Pharmaceutical Co., Ltd.CompletedOcular Hypertension | Open-Angle GlaucomaJapan
-
Santen Inc.CompletedOcular Hypertension | Open-angle GlaucomaUnited States
-
University of Wisconsin, MadisonAgency for Healthcare Research and Quality (AHRQ)CompletedClostridium Difficile Infection | CDI | C.Difficile DiarrheaUnited States
-
Santen Inc.CompletedA Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Patients With POAG or OHTGlaucoma and Ocular HypertensionUnited States
-
University of Erlangen-Nürnberg Medical SchoolUnknown