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).
Study Type
OBSERVATIONAL
Enrollment
237
Small incision lenticule extraction, a refractive surgery procedure for the corrcetion of myopia with or without astigmatism
Department of Clinical Medicine - Department of Ophthalmology
Aarhus, Denmark
University Medical Center Universitätsklinikum Gießen Marburg
Marburg, Germany
Smile Eyes Airport München
München, Germany
HKSH Healthcare Guy Hugh Chan Refractive Surgery Centre
Hong Kong, Hong Kong
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%
Time frame: 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%
Time frame: 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%
Time frame: 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%
Time frame: 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%
Time frame: 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%
Time frame: 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%
Time frame: 3 months
Accuracy of astigmatism
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Medical Center Nethradhama Superspeciality Eye Hospital
Bangalore, India
Determination of the percentage of eyes with absolute post-OP astigmatism within ±0.5D with a half width of 95% confidence-interval of 4%
Time frame: 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
Time frame: 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
Time frame: 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%.
Time frame: 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%.
Time frame: 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%.
Time frame: 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%.
Time frame: 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%.
Time frame: 6 months
CDVA
Distribution of post-op CDVA change against baseline and Cumulative distribution of post-operative CDVA
Time frame: 1 week
CDVA
Distribution of post-op CDVA change against baseline and Cumulative distribution of post-operative CDVA
Time frame: 1 month
CDVA
Distribution of post-op CDVA change against baseline and Cumulative distribution of post-operative CDVA
Time frame: 3 months
CDVA
Distribution of post-op CDVA change against baseline and Cumulative distribution of post-operative CDVA
Time frame: 6 months
Mesopic contrast sensitivity
Mesopic contrast sensitivity and change against baseline
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months
Stability
Stability of MRSE and Astigmatism (change between 2 consecutive timepoints)
Time frame: between 1 month 3 months
Stability
Stability of MRSE and Astigmatism (change between 2 consecutive timepoints)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Patient Questionnaire
Aspects of PROWL patient questionnaire. Change against baseline.
Time frame: 6 months
Corneal wave-front, change against baseline
Simple statistics on corneal wave-front parameters (higher order RMS, Coma and Spherical aberration)
Time frame: 6 months
Centration
Analysis of achieved centration based on centration parameters of device.
Time frame: during the procedure