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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04654455
Acronym
PREPADROP
Enrollment
10
Registered
2020-12-04
Start date
2021-03-09
Completion date
2021-11-02
Last updated
2021-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ametropia

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®.

Interventions

OTHERDescribe 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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Variation in OSDI (Ocular Surface Disease Index) score3 MonthsVariation 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026