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

August 25, 2025 updated by: Carl Zeiss Meditec, Inc.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
186

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Senior Clinical Research Clinical Scientist
  • Phone Number: 925-557-4513
  • Email: todd.otani@zeiss.com

Study Locations

  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72704
        • Vold Vision
    • California
      • Rowland Heights, California, United States, 91748
        • IQ Laser Vision
    • Kansas
      • Leawood, Kansas, United States, 66211
        • Discover Vision Centers
    • Maryland
      • Columbia, Maryland, United States, 21045
        • Goel Vision
    • Ohio
      • Brecksville, Ohio, United States, 44141
        • Cleveland Eye Clinic
    • Texas
      • San Antonio, Texas, United States, 78229
        • Parkhurst NuVision
    • Washington
      • Seattle, Washington, United States, 98125
        • Northwest Eye Surgeons

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Development of clinically relevant visual symptoms via questionnaire responses
Time Frame: 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)
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Resolution of clinically relevant visual symptoms via questionnaire responses
Time Frame: 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)
6 months
Development and resolution of all visual symptoms via questionnaire responses
Time Frame: 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)
6 months
Dry eye via questionnaire responses
Time Frame: 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)
6 months
Satisfaction via questionnaire responses
Time Frame: 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)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Carl Zeiss Meditec, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 5, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 25, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VisuMax-2018-PAS01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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