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

Official title

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

Overview

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

Primary outcome measures

• Loss of more than 2 lines of CDVA [Time frame: Baseline, 12 months, 5 years]
• Manifest refractive astigmatism greater than 2.0 D [Time frame: 5 years]
• MRSE stability within ±1.0 D [Time frame: 12 months, 5 years]
• CDVA worse than 20/40 [Time frame: 5 years]
• UDVA better than 20/40 [Time frame: 5 years]
• MRSE target within ±0.5 D [Time frame: 5 years]
• MRSE target within ±1.0 D [Time frame: 5 years]

Secondary outcome measures (12)

• Change in CDVA [Time frame: Baseline, 12 months, 5 years]
• Distribution of CDVA [Time frame: Baseline, 12 months, 5 years]
• Distribution of UDVA [Time frame: Baseline, 12 months, 5 years]
• Distribution of UNVA [Time frame: Baseline, 12 months, 5 years]
• Distribution of MRSE [Time frame: Baseline, 12 months, 5 years]
• Change of MRSE [Time frame: Baseline, 12 months, 5 years]
• Change of subjective refractive astigmatism [Time frame: Baseline, 12 months, 5 years]
• Adverse events incidence [Time frame: Baseline, 12 months, 5 years]
• Quality of vision [Time frame: 5 years]
• Contrast sensitivity changes [Time frame: Baseline, 12 months, 5 years]
• Change in corneal keratometry [Time frame: Baseline, 12 months, 5 years]
• Change in higher order corneal abberations [Time frame: Baseline, 12 months, 5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Czechia · 1 center

• Gemini Eye Clinic — Zlín

Germany · 1 center

• Universitätsklinikum Marburg - Klinik für Augenheilkunde — Marburg

Publications

• 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. PMID 21229953

Identifiers

NCT: NCT07133737 · PHOBOS-5FU

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗