PMCF Study on SMILE Treatment of Myopia With and Without Astigmatism

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

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.

Study Overview

• Status: Completed
• Conditions: Astigmatism; Myopia
• Intervention / Treatment: Device: SMILE

Detailed Description

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 (Actual): 237

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Department of Clinical Medicine - Department of Ophthalmology
• Germany
  • Marburg, Germany
    • University Medical Center Universitätsklinikum Gießen Marburg
  • München, Germany, 85356
    • Smile Eyes Airport München
• Hong Kong
  • Hong Kong, Hong Kong
    • HKSH Healthcare Guy Hugh Chan Refractive Surgery Centre
• India
  • Bangalore, India
    • Medical Center Nethradhama Superspeciality Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Carl Zeiss Meditec AG
• Collaborators: In Vitro Research Solutions Pvt Ltd (iVRS)
• Investigators: Principal Investigator: Jesper Hjortdal, Prof., Department of Clinical Medicine - Department of Ophthalmology

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2021
• Primary Completion (Actual): March 25, 2023
• Study Completion (Actual): March 25, 2023

Study Registration Dates

• First Submitted: May 4, 2021
• First Submitted That Met QC Criteria: May 7, 2021
• First Posted (Actual): May 13, 2021

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: SMILE; Astigmatism; Myopia
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism; Myopia
• Other Study ID Numbers: V1902PM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no data sharing planned.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No