Safety and Effectiveness of the CustomFlex Artificial Iris Prosthesis for the Treatment of Iris Defects

NCT01860612 | Unknown FDA Device

• 1 other identifier: AI-001
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 13

Brief Summary

The purpose of this study is to study the long term safety and effectiveness of an artificial iris prosthesis for the treatment of iris defects.

Conditions

Full Aniridia; Partial Aniridia

Outcome Measures

Primary Outcomes (3)

• Changes in Symptoms

  Quality of vision will be assessed using the National Eye Institute Visual Functioning Questionnaire - 25.

  SCR & 6 Month

• Participant Satisfaction

  Participant satisfaction will be assessed using the Global Aesthetic Improvement Scale.

  SCR & 6 Month

• Complications and Adverse Events

  Complications and adverse events will be assessed through tabulation of adverse events, changes in vision, cell density, intraocular pressure, and slit lamp exam.

  SCR & 6 Month

Study Arms (3)

PMA Cohort

EXPERIMENTAL

Study participants that meet the inclusion/exclusion criteria for the study may be enrolled in the compassionate use treatment arm. The artificial iris will be implanted in the eye with an iris defect. The fellow eye can be treated 1 month after the primary eye.

Device: Artificial Iris (CustomFlex)

Compassionate Use Cohort

EXPERIMENTAL

Study participants that do not meet the inclusion/exclusion criteria for the study may be enrolled in the compassionate use treatment arm. The artificial iris will be implanted in the eye with an iris defect. The fellow eye can be treated 1 month after the primary eye.

Device: Artificial Iris (CustomFlex)

Continued Access Cohort

EXPERIMENTAL

Study participants that meet the inclusion/exclusion criteria for the study may be enrolled in the Continued Access cohort, after enrollment in the PMA cohort is complete.The fellow eye can be treated 1 month after the primary eye.

Device: Artificial Iris (CustomFlex)

Interventions

Artificial Iris (CustomFlex) DEVICE

Compassionate Use Cohort; Continued Access Cohort; PMA Cohort

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• For the IDE study, subjects in whom the subject and study eye meet all of the following criteria were candidates for the PMA cohort of this study, or the Continued Access cohort after the PMA cohort was enrolled:
• years of age or older
• Having a diagnosis of congenital or acquired full or partial iris defect in the study eye.
• Having symptoms of light sensitivity, photophobia, and/or glare in the study eye.
• Subjects should be pseudophakic, aphakic or require cataract extraction.
• Signed and received a copy of the signed written informed consent.
• Willingness and ability to comply with schedule for follow-up visits and postoperative evaluations.
• Previous AI-001 IDE study participant who was enrolled before PMA approval (i.e., before May 30, 2018) and has had the CustomFlex™ Artificial Iris implanted for 36 months or less if enrolled as an adult or for 60 months or less if enrolled as a pediatric subject.
• Signed and received a copy of the signed written informed consent.
• Willingness and ability to comply with schedule for follow-up visits and postoperative evaluations.
• Pediatric subjects in whom the subject and study eye meet all of the following criteria are candidates for enrollment in the Pediatric New Enrollment Cohort:
• Age between 3 years and less than 22 years at the time of consent for the OSB PAS.
• Having a diagnosis of congenital or acquired full or partial iris defect in the study eye.
• Having symptoms of light sensitivity, photophobia, and/or glare or other aniridic symptoms in the study eye.
• Subjects should be pseudophakic, aphakic or require cataract extraction.

You may not qualify if:

• For the IDE study, all subjects in whom the subject or study eye meets any of the following criteria will were excluded from the PMA cohort of this study, or the Continued Access cohort after the PMA cohort was enrolled:
• Uncontrolled ocular inflammation (e.g., uveitis).
• Preoperative intraocular pressure \> 21 mm Hg.
• Subjects with a current condition that, in the investigator's opinion, would interfere with the treatment.
• Subjects with any of the following conditions:
• Severe chronic uveitis
• Microphthalmus
• Untreated retinal detachment
• Untreated chronic glaucoma
• Rubella cataract
• Rubeosis of the iris
• Proliferative diabetic retinopathy
• Female subjects who are pregnant or lactating at the time of surgery.
• Subjects with a known sensitivity to required postoperative study medications (4th generation fluoroquinolone or steroid anti-inflammatory) if an alternative medication is not available.
• Subjects under legal guardianship or who, in the investigator's opinion, lack the mental capacity to provide written informed consent for study participation.

Sponsors & Collaborators

• Clinical Research Consultants, Inc.: lead
• HumanOptics AG: collaborator

Study Sites (13)

Advanced Vision Care

Los Angeles, California, 90067, United States

RECRUITING

Jules Stein Eye Institute

Los Angeles, California, 90095, United States

COMPLETED

Woolfson Eye Institute

Atlanta, Georgia, 30328, United States

WITHDRAWN

Eye Consultants of Atlanta

Atlanta, Georgia, 30339, United States

COMPLETED

Price Vision Group

Indianapolis, Indiana, 46260, United States

COMPLETED

Minnesota Eye Consultants

Bloomington, Minnesota, 55431, United States

ACTIVE NOT RECRUITING

The Mackool Eye Institute

Astoria, New York, 11103, United States

COMPLETED

Rosenthal Eye Surgery

Great Neck, New York, 11023, United States

COMPLETED

Cincinnati Eye Institute

Cincinnati, Ohio, 45242, United States

RECRUITING

Oregon Eye Associates

Eugene, Oregon, 97401, United States

COMPLETED

Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Alkek Eye Center/ Baylor College of Medicine

Houston, Texas, 77030, United States

COMPLETED

The Eye Institute of Utah

Salt Lake City, Utah, 84107, United States

COMPLETED

Central Study Contacts

Barbara Fant

CONTACT

513-961-8200; bsfant@crc-regulatory.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: May 23, 2013
• Study Start: October 1, 2013
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 24, 2022

Record last verified: 2022-10

Locations

US (13)