Clinical trial NCT05740293: Post-approval Study of New Enrolment Patients Undergoing Bilateral Treatment With the VisuMax SMILE Procedure
Official title: Post-approval Study of New Enrolment Patients Undergoing Bilateral Treatment With the VisuMax SMILE Procedure
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Myopia
Astigmatism
Lead sponsor: Carl Zeiss Meditec, Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-23
Enrollment: 171
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Development of clinically relevant visual symptoms via questionnaire responses
timeFrame: 6 months
Secondary outcomes:
measure: Resolution of clinically relevant visual symptoms via questionnaire responses
timeFrame: 6 months
measure: Development and resolution of all visual symptoms via questionnaire responses
timeFrame: 6 months
measure: Dry eye via questionnaire responses
timeFrame: 6 months
measure: Satisfaction via questionnaire responses
timeFrame: 6 months
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Vold Vision
state: Arkansas
city: Rowland Heights
country: United States
facility: IQ Laser Vision
state: California
city: Leawood
country: United States
facility: Discover Vision Centers
state: Kansas
city: Columbia
country: United States
facility: Goel Vision
state: Maryland
city: Brecksville
country: United States
facility: Cleveland Eye Clinic
state: Ohio
city: San Antonio
country: United States
facility: Parkhurst NuVision
state: Texas
city: Seattle
country: United States
facility: Northwest Eye Surgeons
state: Washington
Study officials:
References: