Hyperopia
Conditions
Keywords
relex, smile, eye surgery, hyperopia
Brief 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
Interventions
None listed
Sponsors
Gemini Eye Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Loss of more than 2 lines of CDVA | Baseline, 12 months, 5 years | Less than 5.0% of eyes loose more than 2 lines of CDVA at 5 years follow-up compared to the baseline visit. |
| Manifest refractive astigmatism greater than 2.0 D | 5 years | Induced manifest refractive astigmatism greater than 2.0 D should occur in less than 5% of subjects at 5 years follow-up. |
| MRSE stability within ±1.0 D | 12 months, 5 years | 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. |
| CDVA worse than 20/40 | 5 years | Less than 1.0% of eyes have a post-operative CDVA worse than 20/40 at 5 years follow-up. |
| UDVA better than 20/40 | 5 years | At least 85% of eyes intended for emmetropia achieve an UDVA of 20/40 or better at 5 years follow-up. |
| MRSE target within ±0.5 D | 5 years | Post-operative SE relative to the intended target should be within ±0.50D in ≥50% of eyes. |
| MRSE target within ±1.0 D | 5 years | Post-operative SE relative to the intended target should be within ±1.00 D ≥75% of eyes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of MRSE | Baseline, 12 months, 5 years | Stability of spherical equivalent refraction |
| Quality of vision | 5 years | 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. |
| Contrast sensitivity changes | Baseline, 12 months, 5 years | 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). |
| Adverse events incidence | Baseline, 12 months, 5 years | Intraoperative and adverse events at each time point (numbers and percentages) |
| Change in higher order corneal abberations | Baseline, 12 months, 5 years | Comparision of higher order corneal abberations with an analysis diameter of 6 mm. |
| Corneal epithelium thickness | 5 years | Analysis of corneal epithelium thickness with an analysis of min-max difference in a diameter of 6 mm. |
| Pentacam Nucleaus Staging | 5 years | Rate of Pentacam Nuclear Staging (PNS) providing a cataract grading score on an ordinal scale (from 0 to 5) where 0 is no cataract. |
| Change in corneal keratometry | Baseline, 12 months, 5 years | Comparision of mean corneal keratometry with an analysis diameter of 6 mm. |
| Change of subjective refractive astigmatism | Baseline, 12 months, 5 years | Stability of subjective refractive astigmatism |
| Change in CDVA | Baseline, 12 months, 5 years | Change in CDVA as a loss-of-line distribution at each time point (safety diagram) |
| Distribution of CDVA | Baseline, 12 months, 5 years | Cumulative distribution of CDVA at each time point including safety index |
| Distribution of UDVA | Baseline, 12 months, 5 years | Cumulative UDVA distribution at each time point compared to pre-operative CDVA |
| Distribution of UNVA | Baseline, 12 months, 5 years | Cumulative UNVA distribution at each time point. |
| Distribution of MRSE | Baseline, 12 months, 5 years | Spherical equivalent refractive accuracy |
Countries
Czechia, Germany
Outcome results
None listed