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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Ametropia
• Refractive Errors

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