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

N/AEnrolling By InvitationNCT07133737

Gemini Eye Clinic100 enrolled

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

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Hyperopia

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (2)

Outcomes

Primary Outcomes

Loss of more than 2 lines of CDVA

Less than 5.0% of eyes loose more than 2 lines of CDVA at 5 years follow-up compared to the baseline visit.

Time frame: Baseline, 12 months, 5 years

Manifest refractive astigmatism greater than 2.0 D

Induced manifest refractive astigmatism greater than 2.0 D should occur in less than 5% of subjects at 5 years follow-up.

Time frame: 5 years

MRSE stability within ±1.0 D

At least 95% of eyes should be stable with a change in Manifest Refractive Spherical Equivalent within ±1D between 12 months and 5 years follow-up visits.

Time frame: 12 months, 5 years

CDVA worse than 20/40

Less than 1.0% of eyes have a post-operative CDVA worse than 20/40 at 5 years follow-up.

Time frame: 5 years

UDVA better than 20/40

At least 85% of eyes intended for emmetropia achieve an UDVA of 20/40 or better at 5 years follow-up.

Time frame: 5 years

MRSE target within ±0.5 D

Post-operative SE relative to the intended target should be within ±0.50D in ≥50% of eyes.

Time frame: 5 years

MRSE target within ±1.0 D

Post-operative SE relative to the intended target should be within ±1.00 D ≥75% of eyes.

Time frame: 5 years

Secondary Outcomes

Change in CDVA

Change in CDVA as a loss-of-line distribution at each time point (safety diagram)

Time frame: Baseline, 12 months, 5 years

Distribution of CDVA

Cumulative distribution of CDVA at each time point including safety index

Time frame: Baseline, 12 months, 5 years

Distribution of UDVA

Cumulative UDVA distribution at each time point compared to pre-operative CDVA

Time frame: Baseline, 12 months, 5 years

Distribution of UNVA

Cumulative UNVA distribution at each time point.

Time frame: Baseline, 12 months, 5 years

Distribution of MRSE

Spherical equivalent refractive accuracy

Time frame: Baseline, 12 months, 5 years

Change of MRSE

Stability of spherical equivalent refraction

Time frame: Baseline, 12 months, 5 years

Change of subjective refractive astigmatism

Stability of subjective refractive astigmatism

Time frame: Baseline, 12 months, 5 years

Adverse events incidence

Intraoperative and adverse events at each time point (numbers and percentages)

Time frame: Baseline, 12 months, 5 years

Quality of vision

Evaluation of patient satisfaction using patient questionnaire with focus on quality of vision. A Rasch-Analysis will be performed based on a questionnaire to evaluate the QoV (Quality of Vision) with a lower score indicating better vision and higher worse vision.

Time frame: 5 years

Contrast sensitivity changes

Determination of contrast sensitivity measured by CSV 1000 (Vector Vision) (changes from the pre-operative to the post-operative state and its stability over time will be investigated).

Time frame: Baseline, 12 months, 5 years

Change in corneal keratometry

Comparision of mean corneal keratometry with an analysis diameter of 6 mm.

Time frame: Baseline, 12 months, 5 years

Change in higher order corneal abberations

Comparision of higher order corneal abberations with an analysis diameter of 6 mm.

Time frame: Baseline, 12 months, 5 years

Corneal epithelium thickness

Analysis of corneal epithelium thickness with an analysis of min-max difference in a diameter of 6 mm.

Time frame: 5 years

Pentacam Nucleaus Staging

Rate of Pentacam Nuclear Staging (PNS) providing a cataract grading score on an ordinal scale (from 0 to 5) where 0 is no cataract.

Time frame: 5 years