PMCF Study on SMILE Treatment of Myopia With and Without Astigmatism

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04884672
• Other study ID #: V1902PM
• Status: Completed
• Start date: July 9, 2021
• Est. completion date: March 25, 2023

Study information

• Verified date: October 2023
• Source: Carl Zeiss Meditec AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: March 25, 2023
• Est. primary completion date: March 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism
• Myopia

Intervention

Device:
• SMILE
Small incision lenticule extraction, a refractive surgery procedure for the corrcetion of myopia with or without astigmatism

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Carl Zeiss Meditec AG	In Vitro Research Solutions Pvt Ltd (iVRS)

Countries where clinical trial is conducted

Denmark,  Germany,  Hong Kong,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	CDVA	Distribution of post-op CDVA change against baseline and Cumulative distribution of post-operative CDVA	1 week
Secondary	CDVA	Distribution of post-op CDVA change against baseline and Cumulative distribution of post-operative CDVA	1 month
Secondary	CDVA	Distribution of post-op CDVA change against baseline and Cumulative distribution of post-operative CDVA	3 months
Secondary	CDVA	Distribution of post-op CDVA change against baseline and Cumulative distribution of post-operative CDVA	6 months
Secondary	Mesopic contrast sensitivity	Mesopic contrast sensitivity and change against baseline	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Stability	Stability of MRSE and Astigmatism (change between 2 consecutive timepoints)	between 1 month 3 months
Secondary	Stability	Stability of MRSE and Astigmatism (change between 2 consecutive timepoints)	between 3 months and 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Patient Questionnaire	Aspects of PROWL patient questionnaire. Change against baseline.	6 months
Secondary	Corneal wave-front, change against baseline	Simple statistics on corneal wave-front parameters (higher order RMS, Coma and Spherical aberration)	6 months
Secondary	Centration	Analysis of achieved centration based on centration parameters of device.	during the procedure