AmetropiaPREPADROPNCT04654455
Prospective Study Evaluating Dry Eye in Patients Operated on for Ametropia by LASIK Surgery and Treated With REPADROP
An observational study of Ametropia, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ametropia
- What is being tested?
- Describe the evolution of dry eye between 1 month and 3 months post-LASIK
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2021to 2 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient admitted to hospital for LASIK surgery for ametropia
Who may be able to join
- Age over 18
- Planned bilateral LASIK surgery
- Use of Repadrop as postoperative eye drops
- Patient agreement to participate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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®.
- Conditions
- Ametropia
- Being tested
- Describe the evolution of dry eye between 1 month and 3 months post-LASIK
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start9 Mar 2021
- Primary completion2 Nov 2021
- Study completion2 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmetropiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654455
- Sponsor's protocol ID
- 69HCL20_1049
- Acronym
- PREPADROP
- Status last verified
- Dec 2021
- First submitted
- 30 Nov 2020
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Evaluating Dry Eye in Patients Operated on for Ametropia by LASIK Surgery and Treated With REPADROP
- ClinicalTrials.gov ID
- NCT04654455
- Acronym / sponsor ID
- PREPADROP / 69HCL20_1049
- Conditions
- Ametropia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 2 Nov 2021 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient admitted to hospital for LASIK surgery for ametropia
Key inclusion criteria (4 listed)
- Age over 18
- Planned bilateral LASIK surgery
- Use of Repadrop as postoperative eye drops
- Patient agreement to participate
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Describe the evolution of dry eye between 1 month and 3 months post-LASIKDry 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. | Other | – |
Primary outcome
Variation in OSDI (Ocular Surface Disease Index) score
Time frame: 3 Months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ametropia, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in OSDI (Ocular Surface Disease Index) score (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021.