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U.S. Department of Health and Human Services

Post-Approval Studies

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Post-Approval Studies

  • 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.


Contact Information

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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Application Number P030016
Current Protocol Accepted 12/22/2005
Study Name OSB Lead-Follow-up Study
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
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 is a a prospective cohort to continue follow-up of the original PMA Cohort of eyes.
Study Population Description Study population is as per device indication. This device is indicated for adults 21-45 years   show the rest ...
Sample Size 526 eyes (294 subjects)
Data Collection Safety Endpoints: Specular microscopy (Endothelial Cell Density count), Secondary ICL Related Surgical Procedures (ICL Removal/Cataract   show the rest ...
Followup Visits and Length of Followup 6, 12, 18, 24, 36, 48, and 60 months
Final Study Results
Actual Number of Patients Enrolled 294
Actual Number of Sites Enrolled 14
Patient Followup Rate 65.3%
Final Safety Findings

Percent change of Endothelial cell loss from baseline to 3 years was 8.18% (SD 7.5%);   show the rest ...
Final Effectiveness Findings

Visual Acuity

The postoperative results demonstrated that the Visian ICL can provide full correction for   show the rest ...
Study Strengths and Weaknesses

The study uses the original IDE cohort following study subjects who had already completed two   show the rest ...
Recommendations for Labeling Changes

Yes. Update labeling with long-term data (5-year).

OSB Lead-Follow-up Study Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
Final IDE report 04/19/2007 04/20/2007 On Time

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