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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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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Post-Approval Study


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General
Study Status Progress Inadequate
Application Number /
Requirement Number
P930016 S053/ PAS001
Date Original Protocol Accepted 01/29/2019
Date Current Protocol Accepted 02/26/2021
Study Name Post-Approval Study
Device Name iDESIGNRefractive Studio, STAR Excimer Laser System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives This study is a multi-center, single-arm, prospective post-approval study in which each subject’s preoperative status is serving as the control for post-surgical outcomes. The study is observational in nature.
Study Population This study will include only subjects undergoing monovision Lasik treatment and who meet all of the study inclusion and exclusion criteria in both eyes. All subjects who meet the inclusion/exclusion criteria will be offered treatment in the study.
Sample Size The study will enroll 383 subjects who have stable myopic refractive error with presbyopia from 8 to 14 sites/investigators across different US geographies. Assuming no more than 30% screen failures and 10% of attrition rate, approximately 268 subjects are to be treated to ensure 241 subjects evaluable at 12 months of follow up.
Key Study Endpoints The study will evaluate: Demographic information, preoperative monovision screening, uncorrected and best corrected vision (monocular and binocular) at distance and near, manifest refraction, and the PROWL scores. All endpoints will be evaluated at preoperative visit and at the postoperative 12-Month visit. The specific endpoints include:
Co-Primary Study Endpoint:
¿Change in driving scale score from preoperative to postoperative as measured by the driving scale within PROWL.
¿The proportion of subjects who required secondary surgery to reverse monovision
Secondary Study Endpoints:
¿The proportion of subjects who experienced bothersome visual symptoms (e.g.,halo, glare, starburst, double images)
¿The proportion of subjects who experienced ‘Moderate to Severe Difficulty with Activities’
¿The proportion of subjects with ‘Satisfaction with Vision’ as measured by PROWL
¿The proportion of subjects with ‘Satisfaction with Surgery’ as measured by PROWL
¿The proportion of subjects who achieve 20/40 or better uncorrected distance and near vision
Exploratory Study Endpoints:
¿The proportion of subjects whose driving scale within PROWL score increases or decreases by more than 8 points from preoperative visit.
¿The proportion of subjects who experience visual symptoms that are severe enough to limit usual activities after undergoing monovision LASIK treatment
¿Baseline subject characteristics associated with difficulties with driving (based on driving scale score) and/or visual symptoms
Other Study Endpoints:
¿UCDVA, monocular (all treated dominant eyes)
¿UCNVA, monocular (all treated eyes)
¿UCIVA, binocular (subjects)
¿BSCVA, monocular (all treated eyes)
¿Depth perception, binocular (subjects)
¿Manifest refraction (all treated eyes)
¿Non-directed visual symptoms
¿Mean change from baseline in visual symptoms via the PROWL questionnaire
¿Adverse event type and rates
Follow-up Visits and Length of Follow-up Eligible subjects who are enrolled in the study will be followed for 12 months, with the frequency of assessments
Preoperative (Within 120 to 14 days prior to surgery)
Operative Day
Postoperative 1 day, 1 week, and 1, 3, 6, 12 months
Interim or Final Data Summary
Interim Results Per the 12-month post approval study status report (3rd year) that the study is currently ongoing per the
protocol. However, the enrollment rate is slower than expected due to complex eligibility criteria, lack of
subjects’ time commitment, decrease in interest in monovision LASIK procedure, and general lack of
interest at qualified sites (details are outlined in Section 12).
The early indication at 12 months in a small number of subjects have demonstrated that the safety and
effectiveness of monovision LASIK of myopic subjects with presbyopia based on the co-primary endpoints
of the mean change in driving scale score from preop to 12 month postop, and reversal rate of monovision
have been achieved. Since the previous annual report, there have been no new device-related or
unanticipated adverse events.
Actual Number of Patients Enrolled 136
Actual Number of Sites Enrolled 8
Patient Follow-up Rate 86.2% (75/87) subjects completed the 3-month visit
70.1% (61/87) of eyes completed the 6-month visit,
57.5% (50/87) of eyes completed the 12-month visit.


Post-Approval Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/14/2018 01/15/2019 Overdue/Received
one year report 06/14/2019 06/19/2019 Overdue/Received
18 month report 12/14/2019 12/10/2019 On Time
two year report 06/14/2020 06/18/2020 Overdue/Received
3 year report 06/14/2021 08/11/2021 Overdue/Received
4 year report 06/14/2022 07/11/2022 Overdue/Received
5 year report 06/14/2023    


Contact Us

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

Additional Resources

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