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

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Completed
• CT.gov ID: NCT04654455
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Actual Duration (Months): 7.8
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief 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®.

Condition or Disease	Intervention/Treatment	Phase
Ametropia	Other: Describe the evolution of dry eye between 1 month and 3 months post-LASIK

Study Design

• Study Type: Observational
• Actual Enrollment: 10 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Study Evaluating Dry Eye in Patients Operated on for Ametropia by LASIK Surgery and Treated With REPADROP
• Actual Study Start Date: Mar 9, 2021
• Actual Primary Completion Date: Nov 2, 2021
• Actual Study Completion Date: Nov 2, 2021

Outcome Measures

Primary Outcome Measures

1. Variation in OSDI (Ocular Surface Disease Index) score [3 Months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Edouard Herriot	Lyon	Rhone	France	69003

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT04654455
• Other Study ID Numbers: 69HCL20_1049
• First Posted: Dec 4, 2020
• Last Update Posted: Dec 9, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Refractive Errors

Study Results

No Results Posted as of Dec 9, 2021