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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| post hyperopia correction | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CDVA | Change in CDVA as a loss-of-line distribution at each time point (safety diagram) | Baseline, 12 months, 5 years |
| Distribution of CDVA | Cumulative distribution of CDVA at each time point including safety index |
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Inclusion Criteria:
Exclusion Criteria:
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The target population are patients who suffered from hyperopia and hyperopia with astigmatism (including presbyopic patients who might have a myopic target) and underwent the original PHOBOS clinical study are medically suitable to undertake the current clinical study investigation.
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| Name | Affiliation | Role |
|---|---|---|
| Pavel Stodulka, Dr. Ph.D, FEBOS-CR | Gemini Eye Clinic | Principal Investigator |
| Anke Messerschmidt-Roth, Dr. rer. medic. | Klinik für Augenheilkunde Marburg | Principal Investigator |
| Walter Sekundo, Prof. Dr. med. | Klinik für Augenheilkunde Marburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gemini Eye Clinic | Zlín | 76001 | Czechia | |||
| Universitätsklinikum Marburg - Klinik für Augenheilkunde |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21229953 | Background | 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. |
| Label | URL |
|---|---|
| the protocol of the original study - ClinicalTrials.gov ID: NCT03431571 | View source |
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| ID | Term |
|---|---|
| D006956 | Hyperopia |
| D012904 | Smiling |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
| D005149 | Facial Expression |
| D009633 | Nonverbal Communication |
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| Baseline, 12 months, 5 years |
| Distribution of UDVA | Cumulative UDVA distribution at each time point compared to pre-operative CDVA | Baseline, 12 months, 5 years |
| Distribution of UNVA | Cumulative UNVA distribution at each time point. | Baseline, 12 months, 5 years |
| Distribution of MRSE | Spherical equivalent refractive accuracy | Baseline, 12 months, 5 years |
| Change of MRSE | Stability of spherical equivalent refraction | Baseline, 12 months, 5 years |
| Change of subjective refractive astigmatism | Stability of subjective refractive astigmatism | Baseline, 12 months, 5 years |
| Adverse events incidence | Intraoperative and adverse events at each time point (numbers and percentages) | 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. | 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). | Baseline, 12 months, 5 years |
| Change in corneal keratometry | Comparision of mean corneal keratometry with an analysis diameter of 6 mm. | Baseline, 12 months, 5 years |
| Change in higher order corneal abberations | Comparision of higher order corneal abberations with an analysis diameter of 6 mm. | 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. | 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. | 5 years |
| Marburg |
| 35043 |
| Germany |
| D003142 |
| Communication |
| D001519 | Behavior |