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Completed

NCT Number: NCT04884672

PMCF Study on SMILE Treatment of Myopia With and Without Astigmatism

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.

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Key information

Conditions

Myopia Astigmatism Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Clinical Medicine - Department of Ophthalmology, Aarhus, Denmark

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SMILE

Device

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

Primary outcomes

  1. Accuracy of manifest spherical equivalent

    Time frame: 1 week

    Determination of the percentage of eyes with MRSE-target SE within

    ±0.5D with a half width of 95% confidence-interval of 4%

  2. Accuracy of manifest spherical equivalent

    Time frame: 1 month

    Determination of the percentage of eyes with MRSE-target SE within

    ±0.5D with a half width of 95% confidence-interval of 4%

  3. Accuracy of manifest spherical equivalent

    Time frame: 3 months

    Determination of the percentage of eyes with MRSE-target SE within

    ±0.5D with a half width of 95% confidence-interval of 4%

  4. Accuracy of manifest spherical equivalent

    Time frame: 6 months

    Determination of the percentage of eyes with MRSE-target SE within

    ±0.5D with a half width of 95% confidence-interval of 4%

  5. Accuracy of astigmatism

    Time frame: 1 week

    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. Accuracy of astigmatism

    Time frame: 1 month

    Determination of the percentage of eyes with absolute post-OP astigmatism within ±0.5D with a half width of 95% confidence-interval of 4%

  7. Accuracy of astigmatism

    Time frame: 3 months

    Determination of the percentage of eyes with absolute post-OP astigmatism within ±0.5D with a half width of 95% confidence-interval of 4%

  8. Accuracy of astigmatism

    Time frame: 6 months

    Determination of the percentage of eyes with absolute post-OP astigmatism within ±0.5D with a half width of 95% confidence-interval of 4%

  9. Early visual acuity

    Time frame: 1 day

    Determination of the difference between post-operative UDVA and pre-operative CDVA with a half width of 95% confidence-interval of 0.02 logMAR

  10. Early visual acuity

    Time frame: 1 week

    Determination of the difference between post-operative UDVA and pre-operative CDVA with a half width of 95% confidence-interval of 0.02 logMAR

  11. Side effects and complications

    Time frame: 1 day

    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%.

  12. Side effects and complications

    Time frame: 1 week

    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%.

  13. Side effects and complications

    Time frame: 1 month

    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%.

  14. Side effects and complications

    Time frame: 3 months

    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%.

  15. Side effects and complications

    Time frame: 6 months

    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%.

Secondary outcomes

  1. CDVA

    Time frame: 1 week

    Distribution of post-op CDVA change against baseline and Cumulative distribution of post-operative CDVA

  2. CDVA

    Time frame: 1 month

    Distribution of post-op CDVA change against baseline and Cumulative distribution of post-operative CDVA

  3. CDVA

    Time frame: 3 months

    Distribution of post-op CDVA change against baseline and Cumulative distribution of post-operative CDVA

  4. CDVA

    Time frame: 6 months

    Distribution of post-op CDVA change against baseline and Cumulative distribution of post-operative CDVA

  5. Mesopic contrast sensitivity

    Time frame: 6 months

    Mesopic contrast sensitivity and change against baseline

  6. UDVA

    Time frame: 1 day

    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)

  7. UDVA

    Time frame: 1 week

    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)

  8. UDVA

    Time frame: 1 month

    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)

  9. UDVA

    Time frame: 3 months

    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)

  10. UDVA

    Time frame: 6 months

    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)

  11. Predictability and accuracy

    Time frame: 1 week

    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

  12. Predictability and accuracy

    Time frame: 1 month

    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

  13. Predictability and accuracy

    Time frame: 3 months

    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

  14. Predictability and accuracy

    Time frame: 6 months

    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

  15. Stability

    Time frame: between 1 month 3 months

    Stability of MRSE and Astigmatism (change between 2 consecutive timepoints)

  16. Stability

    Time frame: between 3 months and 6 months

    Stability of MRSE and Astigmatism (change between 2 consecutive timepoints)

  17. Cylinder vector analyses

    Time frame: 1 week

    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.

  18. Cylinder vector analyses

    Time frame: 1 month

    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.

  19. Cylinder vector analyses

    Time frame: 3 months

    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.

  20. Cylinder vector analyses

    Time frame: 6 months

    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.

  21. Patient Questionnaire

    Time frame: 6 months

    Aspects of PROWL patient questionnaire. Change against baseline.

  22. Corneal wave-front, change against baseline

    Time frame: 6 months

    Simple statistics on corneal wave-front parameters (higher order RMS, Coma and Spherical aberration)

  23. Centration

    Time frame: during the procedure

    Analysis of achieved centration based on centration parameters of device.

Sponsors and collaborators

Lead sponsor

Carl Zeiss Meditec AG

Industry

Collaborators

  • In Vitro Research Solutions Pvt Ltd (iVRS)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 13, 2021
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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