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CompletedNCT04654455PREPADROPUpdated Dec 9, 2021

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

An observational study in Ametropia, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-09.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
18 Years and older
Sex
All
01

Study 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®.

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Conditions studied

  • Ametropia

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03

In context

Refractive Errors

413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.

This study's enrollment of 10 is below the median of 150 across 107 observational studies indexed under Refractive Errors.

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Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient admitted to hospital for LASIK surgery for ametropia

Inclusion criteria

Age over 18

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (actual)
Patient registry
No

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.

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What researchers measure

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.

    Time frame: 3 Months

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Study locations

1 site
  • Hôpital Edouard Herriot
    Lyon, Rhone 69003, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04654455
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Dec 4, 2020
Start date
Mar 9, 2021
Primary completion
Nov 2, 2021
Completion
Nov 2, 2021
Last update
Dec 9, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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