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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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VisuMax SMILE New Enrollment


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General
Study Status Study Pending
Application Number P150040 S003/ PAS001
Date Current Protocol Accepted  
Study Name VisuMax SMILE New Enrollment
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design 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 or without astigmatism. Each patient’s preoperative status is serving as the control for post-operative endpoints.
Study Population Description The validation phase will enroll one group of five (5) to eight (8) patients P150040-S003 VisuMax Femtosecond Laser Page 11 of 32

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 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.
Sample Size 171 subjects from up to 10 investigational sites. Assuming a 10% of lossto-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.
Data Collection 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

Secondary study endpoints

Resolution of clinically relevant visual symptoms:

Proportion of patients that showed resolution of “very” or “extremely” bothersome 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)
Follow-up Visits and Length of Follow-up Eligible patients who are enrolled in the study will be followed for 6

months


VisuMax SMILE New Enrollment Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 01/25/2020    
one year report 07/25/2020    
18 month report 01/25/2021    
two year report 07/25/2021    
three year report 07/25/2022    
four year report 07/25/2023    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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