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

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®.

Study Overview

• Status: Completed
• Conditions: Ametropia
• Intervention / Treatment: Other: Describe the evolution of dry eye between 1 month and 3 months post-LASIK

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• France
  • Rhone
    • Lyon, Rhone, France, 69003
      • Hopital Edouard Herriot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient admitted to hospital for LASIK surgery for ametropia

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 9, 2021
• Primary Completion (ACTUAL): November 2, 2021
• Study Completion (ACTUAL): November 2, 2021

Study Registration Dates

• First Submitted: November 30, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (ACTUAL): December 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 9, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: 69HCL20_1049

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No