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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-IMT PAS 01 New Enrollment Study


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General
Application Number P050034 / PAS001
Current Plan Approved 01/27/2015
Study Name OSB Lead-IMT PAS 01 New Enrollment 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 The objective of the study is to assess the safety of the

intraocular telescope as measured by the cumulative incidence of patients who within 5 years after implantation experience persistent vision-impairing corneal edema (corneal edema leading to persistent loss of best corrected distance visual acuity >2 lines from pre-surgery baseline level).

Interventional, prospective, multicenter, open label, single group assignment, safety study.

Study Population Description The intraocular telescope is indicated for monocular implantation to improve vision in patients greater than or equal to 65 years of age with stable severe (distance BCVA of 20/160 or poorer) to profound (distance BCVA of 20/800 or better) vision impairment caused by bilateral central scotomas associated with end-stage age-related macular degeneration.



Patients must:

¿ have retinal findings of geographic atrophy or disciform scar with foveal involvement, as determined by fluorescein angiography

¿ have evidence of visually significant cataract (>Grade 2)

¿ agree to undergo preoperative training in the use of a trial external telescope to verify:

- at least a five-letter improvement on the ETDRS chart with a trial external telescope

- adequate peripheral vision in the eye not scheduled for surgery

¿ agree to participate in a postoperative visual training

rehabilitation.

Sample Size The sample size of 770 Subjects was calculated under the following assumptions: Two-sided type I error = 0.05. Power of 95%.

Over a five year period from implantation, the true percentage of

patients experiencing the primary outcome is 12%.

The proportion of the population that is ¿lost¿ (i.e., dies, does not return for a visit, or is lost to follow-up) is 15% each year.

Kaplan- Meier curves will be calculated to describe the time course of persistent vision ¿impairing corneal edema.

The Greenwood formula will be used to calculate the variance of the five-year event rate.

The minimum and maximum numbers of sites participating in IMT- PAS-01 are 20 and 50 .

Data Collection The clinical parameters to be evaluated in both eyes at study visits are:

1. Best spectacle-corrected distance acuity, using ETDRS charts

2. Slit lamp examination

3. Fundus examination by indirect ophthalmoscopy

4. Intraocular pressure

5. Adverse events.
Follow-up Visits and Length of Follow-up 5 years

¿Study entry

¿Operative

¿Postoperative day 1 (18-36 hours)

¿Day 7 (+/- 2 days)

¿1 Month (+/- 1 week)

¿3 Months (+/- 1 month)

¿6 Months (+/- 1 month)

¿12 Months (+/- 3 months)

¿24 Months (+/- 3 months)

¿36 Months (+/- 3 months)

¿48 Months (+/- 3 months)

¿60 Months (+/- 3 months)



OSB Lead-IMT PAS 01 New Enrollment Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 12/30/2010 12/22/2010 On Time
1 year report 07/01/2011 06/15/2011 On Time
18 month report 12/30/2011 12/27/2011 On Time
2 year report 06/30/2012 07/02/2012 Overdue/Received
3 year report 06/30/2013 06/24/2013 On Time
4 year report 06/30/2014 07/03/2014 Overdue/Received
5 year report 06/30/2015 06/26/2015 On Time
6 year report 06/30/2016 07/01/2016 Overdue/Received
7 year report 06/30/2017    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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