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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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OSB Lead-Follow-up Study

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Study Status Completed
Application Number P030016 / PAS002
Date Current Protocol Accepted 12/22/2005
Study Name OSB Lead-Follow-up Study
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 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 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 526 eyes (294 subjects)
Data Collection Safety Endpoints: Specular microscopy (Endothelial Cell Density count), Secondary ICL Related Surgical Procedures (ICL Removal/Cataract Extraction, ICL Replacement, ICL Repositioning),

Crystalline lens evaluation (Lens Opacity), Complications/Adverse Reactions, Intraocular Pressure (IOP) change, Biomicroscopy, Gonioscopy. Effectiveness Endpoints: Best Spectacle, Corrected Visual Acuity (BSCVA) over time, Best Spectacle Corrected Visual Acuity (BSCVA) in Patients with Preop BSCVA 20/20 or Better, Comparison of Preoperative BSCVA to 5 Year Postoperative BSCVA, Change in BSCVA, Uncorrected Visual Acuity (UCVA) - Distance, Manifest Refraction Spherical Equivalent (MRSE)
Follow-up Visits and Length of Follow-up 6, 12, 18, 24, 36, 48, and 60 months
Interim or Final Data Summary
Interim Safety Information Study Final Report received and it is still under FDA Review. Some results: The cell loss between baseline and the three -month visit was 2.2% and between three - month and one- year visit was 0.8%. Over the following two consecutive years, the rate of cell loss appeared to increase, however very slightly, from 2.2% between one and two years postoperatively to 2.9% between two and three years postoperatively. After the three year period, cell loss declined to -2.6% between 3 and 4 years and -2.1% between 4 and 5 years.
Actual Number of Patients Enrolled 294
Actual Number of Sites Enrolled 14
Patient Follow-up Rate 65.3%
Final Safety Findings

Percent change of Endothelial cell loss from baseline to 3 years was 8.18% (SD 7.5%); from baseline to 4 years was 10.1% (SD 8.5%); and from baseline to 5 years was 13.9% (SD 8.7%). Endothelial cell loss over time in persons with extremely high myopia is unknown. Other safety findings for adverse events show none exceeding FDA grid except retinal detachment of 0.6% (FDA grid 0.3%), and surgical reintervention of 4.4% (FDA grid 0.8%). However, surgical reinterventions were not shown to have an impact on safety or efficacy.

Other Complications

Postoperatively Intraocular Pressure (IOP)>25 mmHg during follow-up or an increase of >10 mmHg over preoperative took place in 14 cases through 5 years (only 7 persisted at last visit) which is 2.7% of the Visian ICL PMA cohort. Only 2 cases (0.4%) in the entire cohort were diagnosed with ocular hypertension and started on pressure lowering medication. No cases (0.0%) in this study exhibited optic nerve or visual field changes characteristic of glaucoma.

Final Effect Findings

Visual Acuity

The postoperative results demonstrated that the Visian ICL can provide full correction for high myopia up to -15D and only partial correction up to -20D.

UCDVA= Uncorrected Distance Visual Acuity, Snellen

Where emmetropia was the goal (+0.50D) and Pre-op Best Spectacle Corrected Visual Acuity (BSCVA) was better than or equal to 20/20, the rate of UCDVA at first year is 66.5%, third year 59.2% and fifth year 52.7%.

BCDVA= Best Corrected Distance Visual Acuity, Snellen

Eyes with Preoperative BCDVA 20/20 or better, the rate at first year is 95.3%, third year 96.6% and fifth year 96.2%.

Study Strengths & Weaknesses

The study uses the original IDE cohort following study subjects who had already completed two years of follow-up; therefore long-term data (5-years) is available sooner (as opposed to having newly enrolled subjects). This is the only PAS sub-study that collected ECD data. However, the five year follow-up rate of 65.3% is less than optimal. Biases could have been introduced due to lost to follow-up; which, can limit the generalizability of study results.

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
Applicant's Reporting Status
Final IDE report 04/19/2007 04/20/2007 On Time

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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