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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VisuMax SMILE procedure for the reduction or elimination of myopia with astigmatism | Procedure | Bilateral treatment with the approved VisuMax SMILE procedure for the reduction or elimination of myopia with astigmatism. |
| Measure | Description | Time Frame |
|---|---|---|
| Development of clinically relevant visual symptoms via questionnaire responses |
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of clinically relevant visual symptoms via questionnaire responses |
|
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vold Vision | Fayetteville | Arkansas | 72704 | United States | ||
| IQ Laser Vision |
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| 6 months |
| Development and resolution of all visual symptoms via questionnaire responses |
| 6 months |
| Dry eye via questionnaire responses |
| 6 months |
| Satisfaction via questionnaire responses |
| 6 months |
| Rowland Heights |
| California |
| 91748 |
| United States |
| Discover Vision Centers | Leawood | Kansas | 66211 | United States |
| Goel Vision | Columbia | Maryland | 21045 | United States |
| Cleveland Eye Clinic | Brecksville | Ohio | 44141 | United States |
| Parkhurst NuVision | San Antonio | Texas | 78229 | United States |
| Northwest Eye Surgeons | Seattle | Washington | 98125 | United States |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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