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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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Pediatric New Enrollment


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General
Study Status Protocol Overdue
Application Number P170039 / PAS002
Study Name Pediatric New Enrollment
General Study Protocol Parameters
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Descriptive
Study Population Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent A (distinctively) : 18-21 yrs
Detailed Study Protocol Parameters
Study Design Description The primary objective of this study is to evaluate the long term safety of the CustomFlex Artificial Iris in adults (up to postoperative 3 years) and pediatrics (up to postoperative 5 years) for the treatment of full or partial aniridia resulting from congenital and acquired iris defects, including but not limited to traumatic iris defects, traumatic mydriasis, and post inflammatory iris sequelae.



The applicant is conducting a continued follow-up of the premarket cohort (AI-001 study) and a new enrollment study for the pediatric population.



The continued follow-up study is a prospective, nonrandomized, multiple cohort, safety study in which the postoperative outcomes of the subjects are compared to their preoperative baseline.



The new enrollment study is a prospective, single arm, new enrollment safety study, in which the postoperative outcomes of the subjects are compared to their preoperative baseline.

Study Population Description For the continued follow-up study, the study population consists of adult and pediatric subjects who participated in the AI-001 IDE study for less than 36 months (adults) or less than 60 months (pediatrics). For the new enrollment study, the study population consists of pediatric subjects implanted post-approval
Sample Size The follow-up conhort will comprise of up to 580 subjects enrolled in the AI-001 study (PMA primary and secondary eyes, continued access and compassionate use cohorts).



Extended follow-up

Up to 580 adult and pediatrics subjects enrolled in one of four AI-001 study cohorts (approved sample size) will be evaluated through 60 months for safety:

• PMA Primary Eyes 180 subjects

• PMA Fellow Eyes (subset of PMA Primary Eyes)

• Continued Access 250 subjects

• Compassionate Use 150 subjects



New enrollment:

For the pediatric PAS, a sample size of 125 enrolled is proposed. The sample size is based on an 80% follow-up rate to ensure that there are 100 evaluable eyes at 5 years post-operative. Enrollment consist of pediatric subjects implanted post-approval, and rollover of 48 pediatric eyes enrolled in the AI-001 study for compassionate use to ensure that 100 pediatric eyes will be available for assessment at 5 years postoperative. The study sites will be the same sites as those in the AI-001 study with the possibility of additional non-IDE sites. A minimum of 7 sites with pediatric subjects is required for the study.



Data Collection The study will evaluate: secondary surgical interventions, implant position, device or surgery related complications, and device malfunction or defects. The specific outcomes include:

Primary Safety Outcomes:

Device Related Adverse Events at 12 Months

<5% experience a >2 line BSCVA loss that is device related

<5% experience BSCVA worse than 20/40, if 20/40 or better pre-op



Secondary Safety Outcomes:

Cumulative Lens (IOL) Related Adverse Events at 12 months

Anisometropia <1%

Glare/halos <1%

Diplopia <1%

<1% need IOL removal or replacement due to lens power calculation error

Other Outcomes:

Cumulative Surgery Related Adverse Events

Endothelial cell density (ECD) changes

Device malfunction or defects

Device related complications



Follow-up Visits and Length of Follow-up 3 years (adults) and 5 years (pediatrics)


Pediatric New Enrollment Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 11/28/2018 12/27/2018 Overdue/Received
one year report 05/30/2019 05/30/2019 On Time
18 month report 11/28/2019    
two year report 05/29/2020    
three year report 05/29/2021    
four year report 05/29/2022    
five year report 05/29/2023    


Contact Us

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

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