In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
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
Followup Visits and Length of Followup
baseline & 1 month
Final Study Results
Actual Number of Patients Enrolled
30
Actual Number of Sites Enrolled
2
Patient Followup Rate
100%
Final 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).
Study Strengths and 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.
Recommendations for Labeling Changes
Labeling should be updated to include a summary of the post-approval study design, results, and
