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

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.

Study Overview

• Status: Completed
• Conditions: Astigmatism; Myopia
• Intervention / Treatment: Procedure: VisuMax SMILE procedure for the reduction or elimination of myopia with astigmatism

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.

• Study Type: Observational
• Enrollment (Actual): 186

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72704
      • Vold Vision
  • California
    • Rowland Heights, California, United States, 91748
      • IQ Laser Vision
  • Kansas
    • Leawood, Kansas, United States, 66211
      • Discover Vision Centers
  • Maryland
    • Columbia, Maryland, United States, 21045
      • Goel Vision
  • Ohio
    • Brecksville, Ohio, United States, 44141
      • Cleveland Eye Clinic
  • Texas
    • San Antonio, Texas, United States, 78229
      • Parkhurst NuVision
  • Washington
    • Seattle, Washington, United States, 98125
      • Northwest Eye Surgeons

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution of clinically relevant visual symptoms via questionnaire responses	Proportion of subjects that showed resolution of "very" or "extremely" bothersome visual symptoms from preoperative (with optical correction) to 6 months postoperatively (without optical correction); Proportion of subjects that showed resolution of 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
Development and resolution of all visual symptoms via questionnaire responses	Proportion of subjects that developed visual symptoms from preoperative (with optical correction) to 6 months postoperatively (without optical correction); Proportion of subjects that showed resolution of visual symptoms from preoperative (with optical correction) to 6 months postoperatively (without optical correction)	6 months
Dry eye via questionnaire responses	Proportion of subjects that developed dry eye symptoms as compared to their preoperative status (OSDI score from normal at preoperative to abnormal at 6 months; categorized according to Miller et al. 2010); Proportion of subjects that showed resolution of dry eye symptoms as compared to their preoperative status (OSDI score from abnormal at preoperative to normal at 6 months; categorized according to Miller et al. 2010)	6 months
Satisfaction via questionnaire responses	Proportion of patients satisfied with their vision after the SMILE procedure (who responded "completely satisfied", "very satisfied", or "somewhat satisfied" to the corresponding questionnaire item); Proportion of patients satisfied with the SMILE procedure (based on a score ≥ 40 in the corresponding 8-item questionnaire domain)	6 months

Collaborators and Investigators

• Sponsor: Carl Zeiss Meditec, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2022
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): August 25, 2025

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Astigmatism
• Other Study ID Numbers: VisuMax-2018-PAS01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No