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NCT04654455 Clinical Trial

Prospective Study Evaluating Dry Eye in Patients Operated on for Ametropia by LASIK Surgery and Treated With REPADROP

Ametropia Clinical Trial

— PREPADROP  

Official title:
Prospective Study Evaluating Dry Eye in Patients Operated on for Ametropia by LASIK Surgery and Treated With REPADROP

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04654455
Other study ID # 69HCL20_1049
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 9, 2021
Est. completion date November 2, 2021

Study information
Verified date December 2021
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

LASIK is a refractive surgery technique widely used in France. Postoperatively, the classic treatment after LASIK consists of instilling drops to reduce dry eyes. REPADROP® is an innovative eye drops stimulating corneal innervation. To date no study has quantified the improvement in dry eye syndrome and thus the quality of life of patients using REPADROP®.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date November 2, 2021
Est. primary completion date November 2, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Age over 18 - Planned bilateral LASIK surgery - Use of Repadrop as postoperative eye drops - Patient agreement to participate Exclusion Criteria: - History of corneal pathology - Diabetes - History of treatment with REPADROP® or CACICOL® or NGF® (other eye drops which are no longer available on the market to date but which would also improve corneal healing) - Ongoing treatment with topical cyclosporine - Presence of punctal plugs - Adults who are the subject of a legal protection measure (guardianship, curators) - Pregnant or breastfeeding women

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Describe the evolution of dry eye between 1 month and 3 months post-LASIK
Dry eye will be assessed through the OSDI (Ocular Surface Disease Index) questionnaire. The questionnaire will be dispensed during consultations by an orthoptist or an intern/junior doctor, at 1 month and at 3 months post-LASIK.

Locations
Country Name City State
France Hôpital Edouard Herriot Lyon Rhone

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Variation in OSDI (Ocular Surface Disease Index) score Variation in OSDI (Ocular Surface Disease Index) score between 1 month and 3 months post-LASIK. The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability. 3 Months
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