PMCF Study on SMILE Treatment of Myopia With and Without Astigmatism

NCT04884672 | Completed

• 1 other identifier: V1902PM
• Study Type: observational
• Target: 237
• Locations: 4 countries
• Sites: 5

Brief 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.

Conditions

Myopia; Astigmatism

Keywords

SMILE; Myopia; Astigmatism

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (23)

• CDVA

  1 week

• CDVA

  1 month

• CDVA

  3 months

• CDVA

  6 months

• Mesopic contrast sensitivity

  6 months

Interventions

SMILE DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carl Zeiss Meditec AG: lead
• In Vitro Research Solutions Pvt Ltd (iVRS): collaborator

Study Sites (5)

Department of Clinical Medicine - Department of Ophthalmology

Aarhus, 8200, Denmark

Location

University Medical Center Universitätsklinikum Gießen Marburg

Marburg, Germany

Location

Smile Eyes Airport München

München, 85356, Germany

Location

HKSH Healthcare Guy Hugh Chan Refractive Surgery Centre

Hong Kong, Hong Kong

Location

Medical Center Nethradhama Superspeciality Eye Hospital

Bangalore, India

Location

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Jesper Hjortdal, Prof.

  Department of Clinical Medicine - Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 13, 2021
• Study Start: July 9, 2021
• Primary Completion: March 25, 2023
• Study Completion: March 25, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1); DE (2); DK (1); HK (1)