5 Year Follow up of SMILE® Procedure for the Correction of Hyperopia
NCT ID: NCT07133737
Last Updated: 2025-08-21
Study Results
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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ENROLLING_BY_INVITATION
100 participants
OBSERVATIONAL
2025-01-01
2025-12-31
Brief Summary
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This study aims to gain long-term insights into the predictability, safety, stability and side effects of the SMILE® pro procedure. It will evaluate the refractive outcome so the findings can optimize treatment nomograms and selection criteria while providing evidence of the long-term stability and predictability of the procedure.
Approximately 100 patients in the Czech Republic and Germany will participate in this study. The study was reviewed and approved by an independent research ethics committee.The study will consist of a single visit, where standard, non-invasive and painless examinations will be performed. The course of this visit will correspond to the patient's last visit five years ago as part of the clinical trial
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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post hyperopia correction
Patients who underwent hyperopia correction surgery using Femtosecond laser system VisuMax with treatment option ReLEx SMILE at least 5 years ago and were part of the original clinical investigation
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients should be able to understand the patient information and willing to sign an informed consent.
* Patients should be willing to comply with all examinations during the visit.
Exclusion Criteria
* Patients not being able to understand and give informed consent.
* Patients who did not underwent the SMILE hyperopic procedure as part of the study referenced PHOBOS.
ALL
No
Sponsors
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Gemini Eye Clinic
INDUSTRY
Responsible Party
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Dr. Pavel Stodulka
Principal Investigator
Principal Investigators
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Pavel Stodulka, Dr. Ph.D, FEBOS-CR
Role: PRINCIPAL_INVESTIGATOR
Gemini Eye Clinic
Anke Messerschmidt-Roth, Dr. rer. medic.
Role: PRINCIPAL_INVESTIGATOR
Klinik für Augenheilkunde Marburg
Walter Sekundo, Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Klinik für Augenheilkunde Marburg
Locations
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Gemini Eye Clinic
Zlín, , Czechia
Universitätsklinikum Marburg - Klinik für Augenheilkunde
Marburg, , Germany
Countries
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References
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Waring GO 3rd, Reinstein DZ, Dupps WJ Jr, Kohnen T, Mamalis N, Rosen ES, Koch DD, Obstbaum SA, Stulting RD. Standardized graphs and terms for refractive surgery results. J Refract Surg. 2011 Jan;27(1):7-9. doi: 10.3928/1081597X-20101116-01. No abstract available.
Related Links
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the protocol of the original study - ClinicalTrials.gov ID: NCT03431571
Other Identifiers
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PHOBOS-5FU
Identifier Type: -
Identifier Source: org_study_id
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