NCT07133737

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

Follow-up Study of at Least 5 Years After a SMILE® Pro Procedure for the Correction of Hyperopia Investigating Long-term Visual Outcomes and Potential Side Effects

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Gemini Eye Clinic · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-09-01
• Completion: 2025-12-31
• First posted: 2025-08-21
• Last updated: 2025-08-21

Locations

2 sites across 2 countries: Czechia, Germany