Full Aniridia, Partial Aniridia
Conditions
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.
Interventions
DEVICEArtificial Iris (CustomFlex)
Sponsors
HumanOptics AG
Clinical Research Consultants, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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: 1. 22 years of age or older 2. Having a diagnosis of congenital or acquired full or partial iris defect in the study eye. 3. Having symptoms of light sensitivity, photophobia, and/or glare in the study eye. 4. Subjects should be pseudophakic, aphakic or require cataract extraction. 5. Signed and received a copy of the signed written informed consent. 6. Willingness and ability to comply with schedule for follow-up visits and postoperative evaluations. All adult and pediatric subjects who participated in the 12-month AI-001 IDE clinical trial who meet the following inclusion criteria are eligible for enrollment in the PAS; hereafter referred to as the Long Term Extension Cohort: 1. 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. 2. Signed and received a copy of the signed written informed consent. 3. 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: 1. Age between 3 years and less than 22 years at the time of consent for the OSB PAS. 2. Having a diagnosis of congenital or acquired full or partial iris defect in the study eye. 3. Having symptoms of light sensitivity, photophobia, and/or glare or other aniridic symptoms in the study eye. 4. Subjects should be pseudophakic, aphakic or require cataract extraction. 5. Signed and received a copy of the signed written informed consent for the OSB PAS. 6. Willingness and ability to comply with schedule for follow-up visits and postoperative evaluations.
Exclusion criteria
There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Symptoms | SCR & 6 Month | Quality of vision will be assessed using the National Eye Institute Visual Functioning Questionnaire - 25. |
| Participant Satisfaction | SCR & 6 Month | Participant satisfaction will be assessed using the Global Aesthetic Improvement Scale. |
| Complications and Adverse Events | SCR & 6 Month | Complications and adverse events will be assessed through tabulation of adverse events, changes in vision, cell density, intraocular pressure, and slit lamp exam. |
Countries
United States
Contacts
Primary ContactBarbara Fant
Outcome results
None listed