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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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Post-Approval Study


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General
Study Status Progress Adequate
Application Number P150034 / PAS001
Date Current Protocol Accepted 02/15/2018
Study Name Post-Approval Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is a new enrollment and continued follow-up of a single-arm, prospective, multicenter study to evaluate the long term safety of the Raindrop® Near Vision Inlay implanted in an emmetropic population (continued follow-up of premarket cohort). All subjects who meet the inclusion criteria will be followed over a 60-month period or 24 months post inlay removal.
Study Population Description Not applicable for this study as this is a continuation study of the IDE cohort and continued enrollment of about 75 subjects per month.
Sample Size Not applicable for this study as this is a continuation study of the IDE cohort.
Data Collection 1. Preservation of best corrected visual acuity

2. Incidence of secondary surgical interventions

Follow-up Visits and Length of Follow-up 60-months

Follow-ups at 1 day, 1 month, 6 months, 12 months, and 24 months. For subjects that have not had inlay removed then examinations will also occur at 48 months and 60 months.
Interim or Final Data Summary
Interim Safety Information Actual Number of Patients Enrolled: 150 subjects



Actual Number of Sites Enrolled: 4 US sites



Interim Results: This update reflects interim data as of July 24, 2018. Subject enrollment has been completed. The study cohort consisted of 150 subjects at various stages of patient follow-up. The first primary safety endpoint was preservation of best-corrected distance visual acuity (BCDVA). 5.3% [8/150] of subjects experienced a persistent BCDVA loss of 2 lines or more at the last available visit. Regarding the secondary primary safety endpoint of the rate of secondary surgical interventions (SSI) over 60 months postoperatively, 12.7% [19/150] of subjects underwent SSI.



FDA publicly communicated on October 23, 2018, regarding two safety concerns identified from the most recent interim study report: the percentage of subjects with corneal haze, and the percentage of subjects requiring device removal. The rate of central corneal haze of any severity was 42% (63/150) at any time point. The rate of corneal haze at any location and of any severity was 75% (113/150). One patient first developed haze 6 months after removal of the device. Study follow-up is ongoing; however, of the subjects who completed 60 months of follow-up, twenty-two subjects developed their first episode of haze at the 60 month visit. The percentage of patients with two or more lines loss of BCDVA caused by corneal haze (2.0%, 3/150) was greater than what was observed at Month 36.



In this study, 31 subjects (20.7%) were treated with steroids for corneal haze at any time. Of patients who still had the device implanted, 23.7% (29/122) were prescribed steroid eyedrops to treat corneal haze. Of these 29 patients who were treated with steroids, 8 patients were treated for 3 months or more, and an additional 10 patients were being actively treated at the time of the study report or left the study while on active treatment.



Of the 150 patients enrolled in the post-approval study, 35 patients (23.3%) have had their device removed (for haze or other reasons) either during the post-approval study or after they exited the IDE study. In addition, some patients continued to have corneal haze after the device was removed.





Post-Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/28/2016 01/23/2017 Overdue/Received
one year report 06/29/2017 06/28/2017 On Time
18 month report 01/31/2018 02/01/2018 Overdue/Received
two year report 08/28/2018 08/28/2018 On Time
three year report 08/29/2019   Overdue
four year report 06/28/2020    
five year report 06/28/2021    


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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