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

NCT05740293 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 186

Last updated 2025-08-29

No results posted yet for this study

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

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • Carl Zeiss Meditec, Inc.

    lead INDUSTRY

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-05
Primary Completion
2024-09-01
Completion
2025-08-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05740293 on ClinicalTrials.gov