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

Active, not recruiting

• Conditions: Astigmatism; Myopia

• Registration Number: NCT05740293
• Lead Sponsor: Carl Zeiss Meditec, Inc.

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.

Study Timeline

• Study Start: 2022-04-05
• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-21
• Study First Posted: 2023-02-23
• Primary Completion: 2024-09-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 171

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of clinically relevant visual symptoms via questionnaire responses	6 months	* 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)

Secondary Outcome Measures

Name	Time	Method
Development and resolution of all visual symptoms via questionnaire responses	6 months	* 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)
Satisfaction via questionnaire responses	6 months	* 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)
Resolution of clinically relevant visual symptoms via questionnaire responses	6 months	* 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)
Dry eye via questionnaire responses	6 months	* 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)

Trial Locations

Locations (7)

Discover Vision Centers; 🇺🇸 Leawood, Kansas, United States

Cleveland Eye Clinic; 🇺🇸 Brecksville, Ohio, United States

IQ Laser Vision; 🇺🇸 Rowland Heights, California, United States

Northwest Eye Surgeons; 🇺🇸 Seattle, Washington, United States

Parkhurst NuVision; 🇺🇸 San Antonio, Texas, United States

Vold Vision; 🇺🇸 Fayetteville, Arkansas, United States

Goel Vision; 🇺🇸 Columbia, Maryland, United States