Post-approval Study of New Enrolment Patients Undergoing Bilateral Treatment With the VisuMax SMI… (NCT05740293) | Clinical Trial Compass
CompletedNot Applicable
Post-approval Study of New Enrolment Patients Undergoing Bilateral Treatment With the VisuMax SMILE Procedure
United States186 participantsStarted 2022-04-05
Plain-language 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.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 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
Exclusion Criteria:
* 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;
* active eye i…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Development of clinically relevant visual symptoms via questionnaire responses