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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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IMT PAS 01 New Enrollment Study


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General
Study Status Progress Adequate
Application Number P050034 / PAS001
Date Current Protocol Accepted 03/22/2019
Study Name 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).

Study Population Description Patients planned for implantation with an Implantable Miniature Telescope.

Inclusion Criteria:

1. Subject must be greater than or equal to 65 years of age.

2. Subject must have stable BCDVA of 20/160 to 20/800 in the study eye.

3. Subject must have geographic atrophy or disciform scar with foveal involvement, as determined by fluorescein angiography.

4. Subject must have evidence of visually significant cataract (greater than or equal to Grade 2) in the study eye.

5. Subject must undergo pre-surgery training and assessment (typically 2 to 4 sessions) with low vision specialists (optometrist or occupational therapist) in the use of an external telescope sufficient for patient assessment and for the patient to make an informed decision.

6. Subject must achieve at least a 1-line improvement (0.1 LogMAR equivalent) in the eye with the use of an external telescope.

7. Subject must have adequate peripheral vision in the fellow eye.

8. Subject must agree to participate in postoperative visual training with a low vision specialist.

9. Subject must meet the following minimum endothelial cell density requirements:

Exclusion Criteria:

1. Subject with Stargardt’s macular dystrophy in either eye.

2. Central anterior chamber depth (ACD) < 3.0 mm (endothelium to anterior surface of the crystalline lens) in the study eye.

3. Presence of corneal stromal or endothelial dystrophies, including guttata in either eye.

4. Cognitive impairment that would interfere with the ability to understand and complete the Acceptance of Risk and Informed Decision Agreement or prevent proper visual training/rehabilitation with the device.

5. Evidence of active choroidal neovascularization (CNV) on fluorescein angiography or treatment for CNV within the past six months in the study eye.

6. Any ophthalmic pathology that compromises the patient’s peripheral vision in the fellow eye.

7. Previous intraocular or corneal surgery of any kind in the study eye, including any type of surgery for either refractive or therapeutic purposes.

8. History of steroid-responsive rise in intraocular pressure, uncontrolled glaucoma, or preoperative IOP >22 mm Hg, while on maximum medication in study eye.

9. Known sensitivity to post-operative medications in either eye.

10. History of eye rubbing or an ocular condition that predisposes them to eye rubbing.

Sample Size A total of 257 patients are targeted for enrollment in order to achieve 150 evaluable patients that complete the study and are included in the primary evaluations.

Data Collection The primary study endpoint will be the occurrence of persistent vision- impairing corneal edema, measured at the last available visit.

A secondary endpoint will be the rate of ECD loss and the incidence of ocular adverse events associated with use of the intraocular telescope as a marketed product will be evaluated. Events of interest include surgical complications, corneal transplantation, retinal detachment, device explant, and device malfunction.

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



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 07/05/2017 Overdue/Received
8 year report 06/29/2018 07/03/2018 Overdue/Received
9 year report 06/29/2019 07/26/2019 Overdue/Received


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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