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

NCT ID: NCT05740293

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 186 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-05
• Study Completion Date: 2025-08-25

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

Bilateral treatment with the approved VisuMax SMILE procedure for the reduction or elimination of myopia with astigmatism.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Carl Zeiss Meditec, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Other Identifiers

VisuMax-2018-PAS01

Identifier Type: -

Identifier Source: org_study_id