Your session is about to expire
← Back to Search
Prosthesis
Artificial Iris Implant for Aniridia
N/A
Recruiting
Research Sponsored by Clinical Research Consultants, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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: 22 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. 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': 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, signed and received a copy of the signed written informed consent for the OSB PAS, willingness and ability to comply with schedule for follow-up visits and postoperative evaluations.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up scr & 6 month
Awards & highlights
Study Summary
This triallooks at how safe & effective an artificial iris prosthesis is for treating iris defects over time.
Who is the study for?
This trial is for adults and children with congenital or acquired iris defects causing light sensitivity, photophobia, or glare. Candidates must be over 22 years old, pseudophakic, aphakic or need cataract extraction. Previous participants of the AI-001 IDE study are also eligible. Exclusions include uncontrolled eye inflammation, severe eye conditions like chronic uveitis or glaucoma, pregnant/lactating women, and those sensitive to post-op medications.Check my eligibility
What is being tested?
The CustomFlex Artificial Iris prosthesis is being tested for long-term safety and effectiveness in treating iris defects. The study includes individuals who have previously participated in a related trial as well as new pediatric cases between the ages of 3 and under 22.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions at the implant site such as swelling or infection; increased intraocular pressure; inflammation; changes in vision; and possible allergic reactions to materials used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ scr & 6 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~scr & 6 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in Symptoms
Complications and Adverse Events
Participant Satisfaction
Trial Design
3Treatment groups
Experimental Treatment
Group I: PMA CohortExperimental Treatment1 Intervention
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.
Group II: Continued Access CohortExperimental Treatment1 Intervention
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.
Group III: Compassionate Use CohortExperimental Treatment1 Intervention
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.
Find a Location
Who is running the clinical trial?
Clinical Research Consultants, Inc.Lead Sponsor
6 Previous Clinical Trials
949 Total Patients Enrolled
HumanOptics AGIndustry Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any eye conditions or health issues that would interfere with the study.
Research Study Groups:
This trial has the following groups:- Group 1: Compassionate Use Cohort
- Group 2: PMA Cohort
- Group 3: Continued Access Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current enrollment quota for this medical experiment?
"Affirmative. According to the information present at clinicaltrials.gov, this research endeavor is presently recruiting participants since its inception on October 1st 2013 and last being revised on October 21st 2022. 500 subjects must be acquired from 3 healthcare institutions for this investigation."
Answered by AI
Is there currently an open enrollment period for participation in this trial?
"According to clinicaltrials.gov, this medical trial is currently seeking participants; it was first posted on October 1st 2013 and the information has since been revised as recently as October 21st 2022."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger