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| Name | Class |
|---|---|
| In Vitro Research Solutions Pvt Ltd (iVRS) | UNKNOWN |
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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.
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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMILE | Device | Small incision lenticule extraction, a refractive surgery procedure for the corrcetion of myopia with or without astigmatism |
| 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% |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The target population for the device are patients with myopia and myopia combined with astigmatism, who are medically suitable for femtosecond laser treatment with the SMILE treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Jesper Hjortdal, Prof. | Department of Clinical Medicine - Department of Ophthalmology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Medicine - Department of Ophthalmology | Aarhus | 8200 | Denmark | |||
| University Medical Center Universitätsklinikum Gießen Marburg |
There is no data sharing planned.
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| 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 |
| 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 |
| Marburg |
| Germany |
| Smile Eyes Airport München | München | 85356 | Germany |
| HKSH Healthcare Guy Hugh Chan Refractive Surgery Centre | Hong Kong | Hong Kong |
| Medical Center Nethradhama Superspeciality Eye Hospital | Bangalore | India |