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

NCT ID: NCT04654455

Last Updated: 2021-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-09

Study Completion Date

2021-11-02

Brief Summary

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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®.

Detailed Description

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Conditions

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Ametropia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Edouard Herriot

Lyon, Rhone, France

Site Status

Countries

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France

Other Identifiers

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69HCL20_1049

Identifier Type: -

Identifier Source: org_study_id