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

NCT05740293 | Completed FDA Device

• 1 other identifier: VisuMax-2018-PAS01
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 7

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.

Conditions

Myopia; Astigmatism

Outcome Measures

Primary Outcomes (1)

• Development of clinically relevant visual symptoms via questionnaire responses

  * Proportion of subjects that developed "very" or "extremely" bothersome visual symptoms from preoperative (with optical correction) to 6 months postoperatively (without optical correction) * Proportion of subjects that developed difficulty performing daily activities (2 highest categories) due to visual symptoms from preoperative (with optical correction) to 6 months postoperatively (without optical correction)

  6 months

Secondary Outcomes (4)

• Resolution of clinically relevant visual symptoms via questionnaire responses

  6 months

• Development and resolution of all visual symptoms via questionnaire responses

  6 months

• Dry eye via questionnaire responses

  6 months

• Satisfaction via questionnaire responses

  6 months

Interventions

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

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

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will enroll and treat a maximum of 171 patients undergoing bilateral treatment with the approved SMILE procedure for the reduction or elimination of myopia with astigmatism from six (6) to ten (10) investigational sites in the U.S.A.

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

Sponsors & Collaborators

• Carl Zeiss Meditec, Inc.: lead

Study Sites (7)

Vold Vision

Fayetteville, Arkansas, 72704, United States

Location

IQ Laser Vision

Rowland Heights, California, 91748, United States

Location

Discover Vision Centers

Leawood, Kansas, 66211, United States

Location

Goel Vision

Columbia, Maryland, 21045, United States

Location

Cleveland Eye Clinic

Brecksville, Ohio, 44141, United States

Location

Parkhurst NuVision

San Antonio, Texas, 78229, United States

Location

Northwest Eye Surgeons

Seattle, Washington, 98125, United States

Location

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 23, 2023
• Study Start: April 5, 2022
• Primary Completion: September 1, 2024
• Study Completion: August 25, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)