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 range22 Years
SexALL
See this in plain English?
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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 iā¦
What they're measuring
1
Development of clinically relevant visual symptoms via questionnaire responses