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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05740293
• Other study ID #: VisuMax-2018-PAS01
• Status: Active, not recruiting
• Start date: April 5, 2022
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: Carl Zeiss Meditec, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 171
• Est. completion date: March 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism
• Myopia

Intervention

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.

Locations

Country	Name	City	State
United States	Cleveland Eye Clinic	Brecksville	Ohio
United States	Goel Vision	Columbia	Maryland
United States	Vold Vision	Fayetteville	Arkansas
United States	Discover Vision Centers	Leawood	Kansas
United States	IQ Laser Vision	Rowland Heights	California
United States	Parkhurst NuVision	San Antonio	Texas
United States	Northwest Eye Surgeons	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Carl Zeiss Meditec, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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