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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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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New Enrollment Study-IC-8 Apthera IOL


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General
Study Status Ongoing
Application Number /
Requirement Number
P210005 / PAS002
Date Original Protocol Accepted 09/20/2022
Date Current Protocol Accepted  
Study Name New Enrollment Study-IC-8 Apthera IOL
Device Name IC-8 Apthera Intraocular Lens (IOL)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Objective: To verify the post-market safety of the IC-8 Apthera IOL after the treatment of posterior capsular opacification (PCO), an expected complication related to IC-8 IOL implantation.
Design: Prospective, multicenter, single-group, non-randomized new enrollment post approval study to assess the post-market safety of the IC-8 Apthera IOL after Nd:YAG laser capsulotomy following sufficient surgeon training of the sponsor-recommended standardized Nd:YAG laser capsulotomy technique.
The study will be conducted in two phases, Phase A and Phase B. Phase A will occur prior to initiating enrollment for Phase B. The objective of Phase A is to develop a clinician-focused training program that ensures proper training for the treatment of PCO, an expected complication related to IC-8 Apthera IOL implantation. Phase A consists of non-interventional, qualitative research to create the clinician-focused training program.
Phase B, which this protocol outlines, will begin after development of the surgical training plan in Phase A is completed and has been accepted by FDA. The objective of Phase B will be to assess the safety of the IC-8 Apthera IOL after the treatment of posterior capsular opacification (PCO) with Nd:YAG laser
Study Population The study population will include subjects previously implanted with the IC-8 Apthera IOL in one eye and a monofocal/monofocal toric IOL in the fellow eye in accordance with the Directions for Use (DFU) for the IC-8 Apthera IOL, who meet all inclusion/exclusion criteria, and who have developed posterior capsular opacification (PCO) following IC-8 Apthera IOL implantation that requires treatment.
A total of 483 subjects will be consented and enrolled in the study to ensure 435 subjects are available to complete the two-year (up to 25-months) follow-up. Each investigator should enroll approximately 20-30 subjects, and no investigator may enroll more than 25% of the intended total enrollment.

Sample Size No. of subjects: 435
The sample size calculation for the study is based on a desired precision around the point estimate for the explant rate.
Assuming an explant rate of 0.5%, a 95% exact (Clopper-Pearson) upper confidence limit with precision of 1.0% (i.e., an upper CL of 1.5%) would require 435 subjects. Taking into account 10% attrition rate over 24 months, the study should enroll 483 subjects that have developed PCO and require treatment to ensure a minimum of 435 subjects are available to complete the 2-year (approximately 24-months) follow-up.
No. of sites: 15 – 20
Sites location: US
Key Study Endpoints Co-Primary Safety Endpoints:
The co-primary safety endpoints and/or parameters include the following: the rate of any additional Nd:YAG treatments beyond the initial Nd:YAG treatment, Nd:YAG outcome and/or complications, IOL-related assessments (including IC-8 Apthera IOL mask appearance and indication of any Nd:YAG damage), rates of secondary surgical interventions (SSI), rates of other serious ocular adverse events (as described in ISO 11979-7 historical grid), rate of each ocular adverse event (including but not limited to the adverse events described in the ISO 11979-7 historical grd), and rates of subjective visual disturbances.
Additional Endpoints:
Other parameters that will be collected in the study include but are not limited to the following: Nd:YAG laser technique details and/or settings, Nd:YAG difficulty; monocular and binocular best-corrected visual acuities; uncorrected visual acuities; rates of device deficiencies.
Patient-reported outcomes (PROs) will be assessed with the Quality of Vision (QoV) instrument (McAlinden 2010) and the Small Aperture Patient Questionnaire (SAPQ).
Follow-up Visits and Length of Follow-up 24 months


New Enrollment Study-IC-8 Apthera IOL Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
interim report 10/20/2022 10/20/2022 On Time
6 month report 01/20/2023    
1 year report 07/22/2023    
18 month report 01/20/2024    
2 year report 07/21/2024    
3 year report 07/21/2025    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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