5 Year Follow up of SMILE® Procedure for the Correction of Hyperopia (PHOBOS-5FU)

Gemini Eye Clinic

Status: Invitation-only

Conditions: Hyperopia

Study type: Observational

Funder types: Industry

Identifiers

NCT07133737

PHOBOS-5FU

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who underwent the SMILE hyperopic procedure as part of the study referenced PHOBOS.
• 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 with severe ocular or generic disorders that would prevent them from completed the visit.
• 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.

Trial design

100 participants in 1 patient group

post hyperopia correction

Description:

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