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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-Axial Lengths

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Application Number P030016 / PAS003
Current Plan Approved 12/22/2005
Study Name OSB Lead-Axial Lengths
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This clinical study is a prospective cohort, two-center, non-randomized study. The objective of this clinical investigation is to assess the effect of the STAAR Myopic Implantable Collamer Lens (Visian ICL) on the measurement of axial length of the eye to determine whether the ICL effects this measurement. This analysis is important for future cataract extractions in patients with an ICL so that the correct IOL power is implanted.
Study Population Description Study population is as per device indication: This device is indicated for adults 21-45 years of age: * to correct myopia ranging from -3.0 diopters to < - 15.0 diopters with less than or equal to 2.5 diopters of astigmatism at the spectacle plane; * to reduce myopia ranging from greater than -15.0 diopters to - 20.0 diopters with less than or equal to 2.5 diopters of astigmatism at the spectacle plane; and,* with an anterior chamber depth (ACD) 3.00 mm or greater, and a stable refractive history within 0.5 diopter for i year prior to implantation.
Sample Size 30 eyes (30 patient)
Data Collection Axial length of the eye
Follow-up Visits and Length of Follow-up baseline & 1 month
Final Study Results
Interim Safety Information Study is completed. See Final Results
Number of Patients 30
Number of Sites 2
Follow-up Rate 100%
Safety Findings 24 of the 30 patients were from Site 1 and 6 patients were from site 2. Eleven were male and 19 female, 29 were Caucasian and one Asian. Safety Summary: No adverse events were observed during the study.

Effectiveness Summary: The ICL power of the lens implanted averaged -10.68D (range -3.50 to -16.00). The pre-op axial length averaged 27.30mm (range 23.69 to 34.32) and the post-op axial length averaged 27.28mm (23.72 to 34.51). The average difference in axial length measurements is -0.02mm (range-0.23 to + 0.19).
Strengths & Weaknesses One of the strenghts is that this was a prospective study. However, the length of follow-up up was just one month post-treatment.
Label Changes Labeling should be updated to include a summary of the post-approval study design, results, and study strengths and limitations.

OSB Lead-Axial Lengths Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
Final Report 08/03/2009 09/03/2009 Overdue/Received
Interim Report 08/03/2009 08/04/2009 Overdue/Received

Contact Us

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

Phone: (301) 796-6134
Fax: (301) 847-8140

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