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.
Study Type
OBSERVATIONAL
Enrollment
186
Bilateral treatment with the approved VisuMax SMILE procedure for the reduction or elimination of myopia with astigmatism.
Vold Vision
Fayetteville, Arkansas, United States
IQ Laser Vision
Rowland Heights, California, United States
Discover Vision Centers
Leawood, Kansas, United States
Goel Vision
Columbia, Maryland, United States
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)
Time frame: 6 months
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)
Time frame: 6 months
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)
Time frame: 6 months
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)
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Cleveland Eye Clinic
Brecksville, Ohio, United States
Parkhurst NuVision
San Antonio, Texas, United States
Northwest Eye Surgeons
Seattle, Washington, United States
Time frame: 6 months
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)
Time frame: 6 months