MyopiaNCT05740293
Post-approval Study of New Enrolment Patients Undergoing Bilateral Treatment With the VisuMax SMILE Procedure
An observational study of Myopia and Astigmatism, run by Carl Zeiss Meditec, Inc. at 7 sites in United States.
Trial summary
The objective of the post-approval study (PAS) is to assess patient experience of visual symptoms 6 months after bilateral treatment with the VisuMax SMILE procedure as measured by a patient questionnaire. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- VisuMax SMILE procedure for the reduction or elimination of myopia with astigmatism
- Type of treatment
- Surgery or procedure
- How many people
- 186 participants
- Where
- 7 sitesUnited States
- Study dates
- 5 Apr 2022to 25 Aug 2025
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will enroll and treat a maximum of 171 patients undergoing bilateral treatment with the approved SMILE procedure for the reduction or elimination of myopia with astigmatism from six (6) to ten (10) investigational sites in the U.S.A.
Who may be able to join
- Eligible for the approved VisuMax SMILE procedure according to the Professional Use Information, i.e.
- Spherical refractive error (in minus cylinder format) from -1.00 D through -10.00 D;
- Refraction spherical equivalent not greater in magnitude than 10.00 D;
- Minimum age of 22 years;
- Documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of ≤ 0.50 D in magnitude.
- Good candidate for SMILE based on the surgeon's assessment of medical and ophthalmic health, cognitive function, and physical and social limitations
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- Intended bilateral SMILE treatment for the correction of myopia with astigmatism (-0.75 to -3.00 D)
- Both eyes targeted for the full distance manifest spherocylindrical refraction
- Fluent English in speaking and reading
- Willingness and ability to return for 6-month postoperative examination
- Signed informed consent
Who cannot join
- Presence of any of the contraindications of the approved SMILE procedure for the reduction or elimination of myopia with astigmatism, i.e.
- a residual stromal bed thickness that is less than 250 microns from the corneal endothelium;
- abnormal corneal topographic findings, e.g. keratoconus, pellucid marginal degeneration;
- ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect);
- irregular or unstable (distorted/not clear) corneal mires on central keratometry images;
- severe dry eye;
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- active eye infection or inflammation;
- recent herpes eye infection or problems resulting from past infection;
- active autoimmune disease or connective tissue disease;
- uncontrolled diabetes;
- uncontrolled glaucoma.
- Previous treatment with any form of refractive surgery
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Cleveland Eye Clinic
Brecksville, Ohio, 44141
Goel Vision
Columbia, Maryland, 21045
Vold Vision
Fayetteville, Arkansas, 72704
Discover Vision Centers
Leawood, Kansas, 66211
IQ Laser Vision
Rowland Heights, California, 91748
Parkhurst NuVision
San Antonio, Texas, 78229
Northwest Eye Surgeons
Seattle, Washington, 98125
About this study
The objective of the post-approval study (PAS) is to assess patient experience of visual symptoms 6 months after bilateral treatment with the VisuMax SMILE procedure as measured by a patient questionnaire.
Read the detailed description
This is a prospective, multicenter, single arm, open-label, observational study of newly enrolled patients undergoing bilateral treatment with the approved SMILE procedure for the reduction or elimination of myopia with astigmatism. Patients complete a self-administered patient questionnaire preoperatively and 6 months postoperatively. Each patient's preoperative status is serving as the control for postoperative endpoints.
- Conditions
- Myopia, Astigmatism
- Being tested
- VisuMax SMILE procedure for the reduction or elimination of myopia with 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.
VisuMax SMILE procedure for the reduction or elimination of myopia with astigmatismProcedure or surgery
Bilateral treatment with the approved VisuMax SMILE procedure for the reduction or elimination of myopia with astigmatism.
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of clinically relevant visual symptoms via questionnaire responses
- Proportion of subjects that developed "very" or "extremely" bothersome visual symptoms from preoperative (with optical correction) to 6 months postoperatively (without optical correction)
- Proportion of subjects that developed difficulty performing daily activities (2 highest categories) due to visual symptoms from preoperative (with optical correction) to 6 months postoperatively (without optical correction)
Measured: 6 months
Secondary outcomes (4)
Resolution of clinically relevant visual symptoms via questionnaire responses
- Proportion of subjects that showed resolution of "very" or "extremely" bothersome visual symptoms from preoperative (with optical correction) to 6 months postoperatively (without optical correction)
- Proportion of subjects that showed resolution of difficulty performing daily activities (2 highest categories) due to visual symptoms from preoperative (with optical correction) to 6 months postoperatively (without optical correction)
Measured: 6 months
Development and resolution of all visual symptoms via questionnaire responses
- Proportion of subjects that developed visual symptoms from preoperative (with optical correction) to 6 months postoperatively (without optical correction)
- Proportion of subjects that showed resolution of visual symptoms from preoperative (with optical correction) to 6 months postoperatively (without optical correction)
Measured: 6 months
Dry eye via questionnaire responses
- Proportion of subjects that developed dry eye symptoms as compared to their preoperative status (OSDI score from normal at preoperative to abnormal at 6 months; categorized according to Miller et al. 2010)
- Proportion of subjects that showed resolution of dry eye symptoms as compared to their preoperative status (OSDI score from abnormal at preoperative to normal at 6 months; categorized according to Miller et al. 2010)
Measured: 6 months
Satisfaction via questionnaire responses
- Proportion of patients satisfied with their vision after the SMILE procedure (who responded "completely satisfied", "very satisfied", or "somewhat satisfied" to the corresponding questionnaire item)
- Proportion of patients satisfied with the SMILE procedure (based on a score ≥ 40 in the corresponding 8-item questionnaire domain)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start5 Apr 2022
- Primary completion1 Sep 2024
- Study completion25 Aug 2025
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
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carl Zeiss Meditec, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740293
- Sponsor's protocol ID
- VisuMax-2018-PAS01
- Status last verified
- Aug 2025
- First submitted
- 7 Feb 2023
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-approval Study of New Enrolment Patients Undergoing Bilateral Treatment With the VisuMax SMILE Procedure
- ClinicalTrials.gov ID
- NCT05740293
- Acronym / sponsor ID
- VisuMax-2018-PAS01
- Conditions
- Myopia, Astigmatism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 25 Aug 2025 (actual)
- First posted
- 23 Feb 2023 (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 objective of the post-approval study (PAS) is to assess patient experience of visual symptoms 6 months after bilateral treatment with the VisuMax SMILE procedure as measured by a patient questionnaire.
Detailed description
This is a prospective, multicenter, single arm, open-label, observational study of newly enrolled patients undergoing bilateral treatment with the approved SMILE procedure for the reduction or elimination of myopia with astigmatism. Patients complete a self-administered patient questionnaire preoperatively and 6 months postoperatively. Each patient's preoperative status is serving as the control for postoperative endpoints.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll and treat a maximum of 171 patients undergoing bilateral treatment with the approved SMILE procedure for the reduction or elimination of myopia with astigmatism from six (6) to ten (10) investigational sites in the U.S.A.
Key inclusion criteria (11 listed)
- Eligible for the approved VisuMax SMILE procedure according to the Professional Use Information, i.e.
- Spherical refractive error (in minus cylinder format) from -1.00 D through -10.00 D;
- Refraction spherical equivalent not greater in magnitude than 10.00 D;
- Minimum age of 22 years;
- Documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of ≤ 0.50 D in magnitude.
Key exclusion criteria (12 listed)
- Presence of any of the contraindications of the approved SMILE procedure for the reduction or elimination of myopia with astigmatism, i.e.
- a residual stromal bed thickness that is less than 250 microns from the corneal endothelium;
- abnormal corneal topographic findings, e.g. keratoconus, pellucid marginal degeneration;
- ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect);
- irregular or unstable (distorted/not clear) corneal mires on central keratometry images;
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 |
|---|---|---|
| VisuMax SMILE procedure for the reduction or elimination of myopia with astigmatismBilateral treatment with the approved VisuMax SMILE procedure for the reduction or elimination of myopia with astigmatism. | Procedure or surgery | – |
Primary outcome
Development of clinically relevant visual symptoms via questionnaire responses
Time frame: 6 months
* Proportion of subjects that developed "very" or "extremely" bothersome visual symptoms from preoperative (with optical correction) to 6 months postoperatively (without optical correction) * Proportion of subjects that developed difficulty performing daily activities (2 highest categories) due to visual symptoms from preoperative (with optical correction) to 6 months postoperatively (without optical correction)
4 secondary outcomes
Resolution of clinically relevant visual symptoms via questionnaire responses
Time frame: 6 months
Development and resolution of all visual symptoms via questionnaire responses
Time frame: 6 months
Dry eye via questionnaire responses
Time frame: 6 months
Satisfaction via questionnaire responses
Time frame: 6 months
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 29 Aug 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: 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, Inc. at 7 sites in United States.
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 11 inclusion and 12 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 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
Development of clinically relevant visual symptoms via questionnaire responses (time frame: 6 months). 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 29 Aug 2025.