MyopiaNCT04884672
PMCF Study on SMILE Treatment of Myopia With and Without Astigmatism
An observational study of Myopia and Astigmatism, run by Carl Zeiss Meditec AG at 5 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- SMILE
- Type of treatment
- Medical device
- How many people
- 237 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 9 Jul 2021to 25 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Germany2 sites
University Medical Center Universitätsklinikum Gießen Marburg
Marburg
Smile Eyes Airport München
München, 85356
Denmark1 site
Department of Clinical Medicine - Department of Ophthalmology
Aarhus, 8200
Hong Kong1 site
HKSH Healthcare Guy Hugh Chan Refractive Surgery Centre
Hong Kong
About this study
Official title: 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.
Read the 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).
- Conditions
- Myopia, Astigmatism
- Being tested
- SMILE
- Keywords
- SMILE, Myopia, Astigmatism
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMILEDevice
Small incision lenticule extraction, a refractive surgery procedure for the corrcetion of myopia with or without astigmatism
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 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%
Measured: 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%
Measured: 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%
Measured: 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%
Measured: 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%
Measured: 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%
Measured: 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%
Measured: 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
Measured: 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
Measured: 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%.
Measured: 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%.
Measured: 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%.
Measured: 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%.
Measured: 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%.
Measured: 6 months
Secondary outcomes (23)
CDVA
Distribution of post-op CDVA change against baseline and Cumulative distribution of post-operative CDVA
Measured: 1 week
CDVA
Distribution of post-op CDVA change against baseline and Cumulative distribution of post-operative CDVA
Measured: 1 month
CDVA
Distribution of post-op CDVA change against baseline and Cumulative distribution of post-operative CDVA
Measured: 3 months
CDVA
Distribution of post-op CDVA change against baseline and Cumulative distribution of post-operative CDVA
Measured: 6 months
Mesopic contrast sensitivity
Mesopic contrast sensitivity and change against baseline
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months
Stability
Stability of MRSE and Astigmatism (change between 2 consecutive timepoints)
Measured: between 1 month 3 months
Stability
Stability of MRSE and Astigmatism (change between 2 consecutive timepoints)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Patient Questionnaire
Aspects of PROWL patient questionnaire. Change against baseline.
Measured: 6 months
Corneal wave-front, change against baseline
Simple statistics on corneal wave-front parameters (higher order RMS, Coma and Spherical aberration)
Measured: 6 months
Centration
Analysis of achieved centration based on centration parameters of device.
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start9 Jul 2021
- Primary completion25 Mar 2023
- Study completion25 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carl Zeiss Meditec AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- In Vitro Research Solutions Pvt Ltd (iVRS)
- Responsible party
- Sponsor
- Investigators
- Jesper Hjortdal, Prof., Principal investigator, Department of Clinical Medicine - Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884672
- Sponsor's protocol ID
- V1902PM
- Status last verified
- Oct 2023
- First submitted
- 4 May 2021
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no data sharing planned.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Follow-up Study on SMILE Treatment of Myopia With and Without Astigmatism by VISUMAX 800
- ClinicalTrials.gov ID
- NCT04884672
- Acronym / sponsor ID
- V1902PM
- Conditions
- Myopia, Astigmatism
- Keywords
- SMILE, Myopia, Astigmatism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec AGIndustry (pharma, biotech, devices)
- Collaborators
- In Vitro Research Solutions Pvt Ltd (iVRS)
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- 25 Mar 2023 (actual)
- Study completion
- 25 Mar 2023 (actual)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMILESmall incision lenticule extraction, a refractive surgery procedure for the corrcetion of myopia with or without astigmatism | Device | – |
Primary outcome
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%
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%
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%
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%
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%
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%
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%
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%
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
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
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%.
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%.
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%.
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%.
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%.
23 secondary outcomes
CDVA
Time frame: 1 week
CDVA
Time frame: 1 month
CDVA
Time frame: 3 months
CDVA
Time frame: 6 months
Mesopic contrast sensitivity
Time frame: 6 months
UDVA
Time frame: 1 day
UDVA
Time frame: 1 week
UDVA
Time frame: 1 month
UDVA
Time frame: 3 months
UDVA
Time frame: 6 months
Predictability and accuracy
Time frame: 1 week
Predictability and accuracy
Time frame: 1 month
Predictability and accuracy
Time frame: 3 months
Predictability and accuracy
Time frame: 6 months
Stability
Time frame: between 1 month 3 months
Stability
Time frame: between 3 months and 6 months
Cylinder vector analyses
Time frame: 1 week
Cylinder vector analyses
Time frame: 1 month
Cylinder vector analyses
Time frame: 3 months
Cylinder vector analyses
Time frame: 6 months
Patient Questionnaire
Time frame: 6 months
Corneal wave-front, change against baseline
Time frame: 6 months
Centration
Time frame: during the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No. There is no data sharing planned.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesper Hjortdal, Prof. principal investigator
Department of Clinical Medicine - Department of Ophthalmology
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia and Astigmatism, run by Carl Zeiss Meditec AG at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Denmark, Hong Kong, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of manifest spherical equivalent (time frame: 1 week). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.