NCT04654455

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®.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

March 9, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2021

Completed
Last Updated

December 9, 2021

Status Verified

December 1, 2021

Enrollment Period

8 months

First QC Date

November 30, 2020

Last Update Submit

December 8, 2021

Conditions

Ametropia

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Describe the evolution of dry eye between 1 month and 3 months post-LASIKOTHER

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient admitted to hospital for LASIK surgery for ametropia

You may qualify if:

  • Age over 18
  • Planned bilateral LASIK surgery
  • Use of Repadrop as postoperative eye drops
  • Patient agreement to participate

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Edouard Herriot

Lyon, Rhone, 69003, France

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2020

First Posted

December 4, 2020

Study Start

March 9, 2021

Primary Completion

November 2, 2021

Study Completion

November 2, 2021

Last Updated

December 9, 2021

Record last verified: 2021-12

Locations

FR(1)