Post-approval Study of New Enrolment Patients Undergoing Bilateral Treatment With the VisuMax SMILE Procedure
Completed
Conditions studied: Myopia, Astigmatism
In brief
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.
Key facts
- Study ID
- NCT05740293
- Run by
- Carl Zeiss Meditec, Inc.
- People needed
- 186
- Starts
- 2022-04-05
- Expected to finish
- 2025-08-25
- Last updated by the study team
- 2025-08-29
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 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
Where it is running
- Vold Vision — Fayetteville, Arkansas, United States
- IQ Laser Vision — Rowland Heights, California, United States
- Discover Vision Centers — Leawood, Kansas, United States
- Goel Vision — Columbia, Maryland, United States
- Cleveland Eye Clinic — Brecksville, Ohio, United States
- Parkhurst NuVision — San Antonio, Texas, United States
- Northwest Eye Surgeons — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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