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5 Year Follow up of SMILE® Procedure for the Correction of Hyperopia

NCT07133737 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-08-21

No results posted yet for this study

Summary

The planned study will investigate and evaluate refractive stability, predictability, and safety in patients who underwent SMILE® pro surgery for hyperopia with or without astigmatism at least five years ago.

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

Conditions

  • Hyperopia

Sponsors & Collaborators

  • Gemini Eye Clinic

    lead INDUSTRY

Principal Investigators

  • Pavel Stodulka, Dr. Ph.D, FEBOS-CR · Gemini Eye Clinic

  • Anke Messerschmidt-Roth, Dr. rer. medic. · Klinik für Augenheilkunde Marburg

  • Walter Sekundo, Prof. Dr. med. · Klinik für Augenheilkunde Marburg

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-09-01
Completion
2025-12-31

Countries

  • Czechia
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07133737 on ClinicalTrials.gov