NCT05740293

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 186 (actual)
• Sponsor: Carl Zeiss Meditec, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-04-05
• Primary completion: 2024-09-01
• Completion: 2025-08-25
• First posted: 2023-02-23
• Last updated: 2025-08-29

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study