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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P150040 S003/ PAS001 |
| Date Original Protocol Accepted |
07/25/2019
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| Date Current Protocol Accepted |
04/13/2023
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| Study Name |
VisuMax SMILE New Enrollment
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| Device Name |
VisuMax Femtosecond Laser
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Device Subjects Serve as Own Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The study is designed to evaluate the patient experience of visual symptoms 6 months after bilateral treatment with the VisuMax SMILE procedure as measured by the Patient-Reported Outcomes with LASIK (PROWL) patient questionnaire. The study will be conducted in two phases. Phase 1 (validation phase) will evaluate the content of the PROWL questionnaire for use with patients previously treated with the SMILE procedure. Phase 2 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 or without astigmatism. Each patient’s preoperative status is serving as the control for post-operative endpoints.
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| Study Population |
The validation phase will enroll one group of five (5) to eight (8) patients P150040-S003 VisuMax Femtosecond Laser that have undergone bilateral SMILE for the reduction or elimination of myopia at least 6 months prior, and another group of five (5) to eight (8) patients that have undergone SMILE with astigmatism at least 6 months prior. The validation phase will be conducted at one (1) study site in the U.S.A. The phase 2 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 or without astigmatism from six (6) to ten (10) investigational sites in the U.S.A.
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| Sample Size |
171 subjects from up to 10 investigational sites. Assuming a 10% of loss to follow-up rate, 171 patients are to be treated to ensure 154 evaluable patients at 6 months of follow up to estimate the primary study endpoints
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| Key Study Endpoints |
All study endpoints refer to assessments based on responses to the corresponding scales of the PROWL questionnaire including: Visual symptoms for double images, glare, halo, and starburst (8 items each, total 32 items), Ocular Surface Disease Index (OSDI) scales for dry eye symptoms and environmental triggers (8 items), Satisfaction with current vision (1 item), Satisfaction with SMILE surgery (8 items). Specific study endpoints include: Primary Safety Outcomes: (PROWL) Development of clinically relevant visual symptoms: Proportion of patients that developed “very” or “extremely” bothersome visual symptoms from preoperative to 6 months postoperatively Proportion of patients that developed difficulty performing daily activities (2 highest categories) due to visual symptoms from preoperative to 6 months postoperatively Sbothersome visual symptoms from preoperative to 6 months postoperatively Proportion of patients that showed resolution of difficulty performing daily activities (2 highest categories) due to visual symptoms from preoperative to 6 months postoperatively Development and resolution of all visual symptoms: Proportion of patients that developed visual symptoms from preoperative to 6 months postoperatively Proportion of patients that showed resolution of visual symptoms from preoperative to 6 months postoperatively Dry eye: Proportion of patients 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 patients 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) Satisfaction: Proportion of patients satisfied with their vision after the SMILE procedure (i.e. “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) Distribution analyses to be performed: Visual symptoms: Distribution of visual symptoms pre- and 6 months postoperatively (with and without optical correction) Distribution of grades of bothersome visual symptoms pre- and 6 months postoperatively (with and without optical correction) Distribution of grades of difficulty with daily activities due to visual symptoms pre- and 6 months postoperatively (with and without optical correction)econdary study endpoints Resolution of clinically relevant visual symptoms: Proportion of patients that showed resolution of “very” or “extremely”
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| Follow-up Visits and Length of Follow-up |
Eligible patients who are enrolled in the study will be followed for 6 months
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
186 enrolled, 171 treated
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| Actual Number of Sites Enrolled |
7
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| Patient Follow-up Rate |
15 subjects were discontinued prior to treatment.. 3 subjects have been lost to follow-up
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