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 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)
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%);
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 Effectiveness 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.
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 and 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).
