PMCF Study on SMILE Treatment of Myopia With and Without Astigmatism

Study Overview
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Brief Summary
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The primary objective of this PMCF investigation is to systematically collect safety and effectiveness data with the VISUMAX 800 laser in clinical daily routine SMILE use for the purpose of post market surveillance.

Detailed Description
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The present PMCF study is a prospective, non-randomized, international multi-center study without control group including patients with myopia or myopia combined with astigmatism undergoing SMILE with the VISUMAX 800 femtosecond laser in daily routine use. In this PMCF study, at maximum 474 eyes of consecutive subjects will be consented, enrolled, treated and followed up to 6 months postoperatively at 4 to 5 sites. The treatments, which will be done bilateral, shall be equally distributed between the sites as far as possible. The subjects will be 18 years of age or older, who suffer from myopia of up to -10 D with or without astigmatism of up to 5 D, and are suitable for SMILE treatments, fulfil all inclusion criteria and not fulfil any of the exclusion criteria. The expected duration of the is 16 months (site initiation to closeout visit).

Official Title
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Post-Market Clinical Follow-up Study on SMILE Treatment of Myopia With and Without Astigmatism by VISUMAX 800

Conditions
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Myopia, Astigmatism

Intervention / Treatment
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* Device: SMILE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Myopia up to -10 D with and without astigmatism up to 5 D Age of 18 years or older Pre-operative CDVA of 20/25 or better in each eye Patient shall be willing to comply with all follow-up visits and the respective examinations Patients should be able to understand the patient information and willing to sign an informed consent. Contact lens wearers must stop wearing their contact lenses at least 2 weeks before baseline measurements in case of hard contact lenses and 2 days before baseline measurements in case of soft contact lenses Exclusion Criteria: No monovision treatments (target sphere may not be more negative than -0.25 D) The patient may not participate in other ophthalmologic studies except in VEMOS study at site Aarhus. Any impaired person (minors, pregnant or breast-feeding women or persons incapable of giving consent) are definitely excluded from the study. The patients presenting at least one of the contraindications stated in User Manual of the VISUMAX 800 option ReLEx SMILE must not be included in this clinical investigation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: SMILE|Small incision lenticule extraction, a refractive surgery procedure for the corrcetion of myopia with or without astigmatism|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of manifest spherical equivalent | Determination of the percentage of eyes with MRSE-target SE within ±0.5D with a half width of 95% confidence-interval of 4% | 1 week | 
| Accuracy of manifest spherical equivalent | Determination of the percentage of eyes with MRSE-target SE within ±0.5D with a half width of 95% confidence-interval of 4% | 1 month | 
| Accuracy of manifest spherical equivalent | Determination of the percentage of eyes with MRSE-target SE within ±0.5D with a half width of 95% confidence-interval of 4% | 3 months | 
| Accuracy of manifest spherical equivalent | Determination of the percentage of eyes with MRSE-target SE within ±0.5D with a half width of 95% confidence-interval of 4% | 6 months | 
| Accuracy of astigmatism | Determination of the percentage of eyes with absolute post-OP astigmatism within ±0.5D with a half width of 95% confidence-interval of 4% | 1 week | 
| Accuracy of astigmatism | Determination of the percentage of eyes with absolute post-OP astigmatism within ±0.5D with a half width of 95% confidence-interval of 4% | 1 month | 
| Accuracy of astigmatism | Determination of the percentage of eyes with absolute post-OP astigmatism within ±0.5D with a half width of 95% confidence-interval of 4% | 3 months | 
| Accuracy of astigmatism | Determination of the percentage of eyes with absolute post-OP astigmatism within ±0.5D with a half width of 95% confidence-interval of 4% | 6 months | 
| Early visual acuity | Determination of the difference between post-operative UDVA and pre-operative CDVA with a half width of 95% confidence-interval of 0.02 logMAR | 1 day | 
| Early visual acuity | Determination of the difference between post-operative UDVA and pre-operative CDVA with a half width of 95% confidence-interval of 0.02 logMAR | 1 week | 
| Side effects and complications | Determination of the rates of side effects and intra-operative complications with an accuracy, which in case of a zero frequency allows the conclusion of being lower or equal than 1%, which means that the upper confidence limit is 1%. | 1 day | 
| Side effects and complications | Determination of the rates of side effects and intra-operative complications with an accuracy, which in case of a zero frequency allows the conclusion of being lower or equal than 1%, which means that the upper confidence limit is 1%. | 1 week | 
| Side effects and complications | Determination of the rates of side effects and intra-operative complications with an accuracy, which in case of a zero frequency allows the conclusion of being lower or equal than 1%, which means that the upper confidence limit is 1%. | 1 month | 
| Side effects and complications | Determination of the rates of side effects and intra-operative complications with an accuracy, which in case of a zero frequency allows the conclusion of being lower or equal than 1%, which means that the upper confidence limit is 1%. | 3 months | 
| Side effects and complications | Determination of the rates of side effects and intra-operative complications with an accuracy, which in case of a zero frequency allows the conclusion of being lower or equal than 1%, which means that the upper confidence limit is 1%. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CDVA | Distribution of post-op CDVA change against baseline and Cumulative distribution of post-operative CDVA | 1 week | 
| CDVA | Distribution of post-op CDVA change against baseline and Cumulative distribution of post-operative CDVA | 1 month | 
| CDVA | Distribution of post-op CDVA change against baseline and Cumulative distribution of post-operative CDVA | 3 months | 
| CDVA | Distribution of post-op CDVA change against baseline and Cumulative distribution of post-operative CDVA | 6 months | 
| Mesopic contrast sensitivity | Mesopic contrast sensitivity and change against baseline | 6 months | 
| UDVA | Cumulative distribution of post-op UDVA (compared to pre-op CDVA) and Distribution of change of UDVA against pre-op CDVA (in units of lines) | 1 day | 
| UDVA | Cumulative distribution of post-op UDVA (compared to pre-op CDVA) and Distribution of change of UDVA against pre-op CDVA (in units of lines) | 1 week | 
| UDVA | Cumulative distribution of post-op UDVA (compared to pre-op CDVA) and Distribution of change of UDVA against pre-op CDVA (in units of lines) | 1 month | 
| UDVA | Cumulative distribution of post-op UDVA (compared to pre-op CDVA) and Distribution of change of UDVA against pre-op CDVA (in units of lines) | 3 months | 
| UDVA | Cumulative distribution of post-op UDVA (compared to pre-op CDVA) and Distribution of change of UDVA against pre-op CDVA (in units of lines) | 6 months | 
| Predictability and accuracy | Predictability plots for attempted versus achieved MRSE including regression analysis and Predictability of astigmatism (vector based) including regression analysis. and Accuracy plots (distribution of pre and post-op MRSE and Astigmatim) and Induced astigmatism | 1 week | 
| Predictability and accuracy | Predictability plots for attempted versus achieved MRSE including regression analysis and Predictability of astigmatism (vector based) including regression analysis. and Accuracy plots (distribution of pre and post-op MRSE and Astigmatim) and Induced astigmatism | 1 month | 
| Predictability and accuracy | Predictability plots for attempted versus achieved MRSE including regression analysis and Predictability of astigmatism (vector based) including regression analysis. and Accuracy plots (distribution of pre and post-op MRSE and Astigmatim) and Induced astigmatism | 3 months | 
| Predictability and accuracy | Predictability plots for attempted versus achieved MRSE including regression analysis and Predictability of astigmatism (vector based) including regression analysis. and Accuracy plots (distribution of pre and post-op MRSE and Astigmatim) and Induced astigmatism | 6 months | 
| Stability | Stability of MRSE and Astigmatism (change between 2 consecutive timepoints) | between 1 month 3 months | 
| Stability | Stability of MRSE and Astigmatism (change between 2 consecutive timepoints) | between 3 months and 6 months | 
| Cylinder vector analyses | Cylinder vector analyses as double angle plots as well as descriptive statistics on: target induced astigmatism, surgical induced astigmatism, correction index, index of success, angle of error, magnitude of error. | 1 week | 
| Cylinder vector analyses | Cylinder vector analyses as double angle plots as well as descriptive statistics on: target induced astigmatism, surgical induced astigmatism, correction index, index of success, angle of error, magnitude of error. | 1 month | 
| Cylinder vector analyses | Cylinder vector analyses as double angle plots as well as descriptive statistics on: target induced astigmatism, surgical induced astigmatism, correction index, index of success, angle of error, magnitude of error. | 3 months | 
| Cylinder vector analyses | Cylinder vector analyses as double angle plots as well as descriptive statistics on: target induced astigmatism, surgical induced astigmatism, correction index, index of success, angle of error, magnitude of error. | 6 months | 
| Patient Questionnaire | Aspects of PROWL patient questionnaire. Change against baseline. | 6 months | 
| Corneal wave-front, change against baseline | Simple statistics on corneal wave-front parameters (higher order RMS, Coma and Spherical aberration) | 6 months | 
| Centration | Analysis of achieved centration based on centration parameters of device. | during the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SMILE, Myopia, Astigmatism