Post-approval Study of New Enrolment Patients Undergoing Bilateral Treatment With the VisuMax SMILE Procedure

Carl Zeiss Meditec

Status: Completed

Conditions: Myopia; Astigmatism

Treatments: Procedure: VisuMax SMILE procedure for the reduction or elimination of myopia with astigmatism

Study type: Observational

Funder types: Industry

Identifiers

NCT05740293

VisuMax-2018-PAS01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 186 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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 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