Full AniridiaNCT01860612

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

A study testing Artificial Iris (CustomFlex) in people with Full Aniridia and Partial Aniridia, run by Clinical Research Consultants, Inc. at 13 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 3 years and older
Conditions the study is for: Full Aniridia, Partial Aniridia
What is being tested?: Artificial Iris (CustomFlex)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 500 participants
Where: 13 sitesUnited States
Study dates: Oct 2013to 31 Dec 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

There are no exclusion criteria for the Long Term Extension Cohort .
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:

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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.
Stargardt's retinopathy.
Subjects with gastric ulcers or diabetes mellitus in whom high doses of postoperative systemic steroids are required.
Surgical difficulty of the planned surgery, which might increase the potential for complications.
No useful vision or vision potential in the fellow eye.
Clear crystalline lens (in eyes with intact natural, crystalline lens).
Implantation of a CustomFlex™ Artificial Iris prosthesis in the contralateral eye within the previous 4 weeks.
In the investigator's opinion, the presence of a condition or finding in the contralateral eye that would make it unsafe to implant a CustomFlex™ Artificial Iris prosthesis in the study eye.
All pediatric subjects in whom the subject or study eye meets any of the following criteria will be excluded from enrollment in the Pediatric New Enrollment Cohort:
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
Intraocular infections
Severe endothelial corneal dystrophy.
Subjects in whom an ocular surgery to treat an existing condition is planned to be performed in the study eye within 6 months after the artificial iris implant surgery day.
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.
Stargardt's retinopathy.
Subjects with gastric ulcers or diabetes mellitus in whom high doses of postoperative systemic steroids are required.
Surgical difficulty of the planned surgery, which might increase the potential for complications.
No useful vision or vision potential in the fellow eye.
Clear crystalline lens (in eyes with intact natural, crystalline lens).
Implantation of a CustomFlex™ Artificial Iris prosthesis in the contralateral eye within the previous 4 weeks.
In the investigator's opinion, the presence of a condition or finding in the contralateral eye that would make it unsafe to implant a CustomFlex™ Artificial Iris prosthesis in the study eye.

Trial locations and contacts

13 sites in 1 country.

Barbara Fant contact

513-961-8200

bsfant@crc-regulatory.com

City, postcode or hospital

Sites recruiting now only

13 sites in 1 country

United States13 sites, 3 recruiting

The Mackool Eye Institute
Astoria, New York, 11103
Completed
Woolfson Eye Institute
Atlanta, Georgia, 30328
Withdrawn
Eye Consultants of Atlanta
Atlanta, Georgia, 30339
Completed
Minnesota Eye Consultants
Bloomington, Minnesota, 55431
Active, not recruiting
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
Amy Jost, 513-984-5133, ajost@cincinnatieye.com
Michael Snyder, M.D.
Recruiting
Oregon Eye Associates
Eugene, Oregon, 97401
Completed
Rosenthal Eye Surgery
Great Neck, New York, 11023
Completed
Alkek Eye Center/ Baylor College of Medicine
Houston, Texas, 77030
Completed
Price Vision Group
Indianapolis, Indiana, 46260
Completed
Advanced Vision Care
Los Angeles, California, 90067
Ory Shiler, 310-229-1220, orlyjr@inorbit.com
Nicole Fram, M.D.
Recruiting
Jules Stein Eye Institute
Los Angeles, California, 90095
Completed
Wills Eye Institute
Philadelphia, Pennsylvania, 19107
Gwen Toti, 877-289-4557, gtoti@oppdoctors.com
Brandon Ayres, M.D.
Recruiting
The Eye Institute of Utah
Salt Lake City, Utah, 84107
Completed

Other trials in United States

About this study

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
Being tested: Artificial Iris (CustomFlex)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Artificial Iris (CustomFlex)Device

Study groups in NCT01860612
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Device: Artificial Iris (CustomFlex)

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in Symptoms
Quality of vision will be assessed using the National Eye Institute Visual Functioning Questionnaire - 25.
Measured: SCR & 6 Month
Participant Satisfaction
Participant satisfaction will be assessed using the Global Aesthetic Improvement Scale.
Measured: 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.
Measured: SCR & 6 Month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 201331 Dec 2025

First posted23 May 2013 (estimated)
Study startOct 2013
Primary completion31 Dec 2025 (estimated)
Study completion31 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Full AniridiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 500 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01860612
Sponsor's protocol ID: AI-001
Status last verified: Oct 2022
First submitted: 20 May 2013
Last updated: 24 Oct 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Effectiveness of the CustomFlex Artificial Iris Prosthesis for the Treatment of Iris Defects
ClinicalTrials.gov ID: NCT01860612
Acronym / sponsor ID: AI-001
Conditions: Full Aniridia, Partial Aniridia
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 500 participants (estimated)
Lead sponsor: Clinical Research Consultants, Inc.Industry (pharma, biotech, devices)
Collaborators: HumanOptics AG
Study start: Oct 2013
Primary completion: 31 Dec 2025 (estimated)
Study completion: 31 Dec 2025 (estimated)
First posted: 23 May 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
PMA Cohort	Experimental	Device: Artificial Iris (CustomFlex)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.
Compassionate Use Cohort	Experimental	Device: Artificial Iris (CustomFlex)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.
Continued Access Cohort	Experimental	Device: Artificial Iris (CustomFlex)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.

Who may qualify

Ages: 3 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (18 listed)

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.

Key exclusion criteria (48 listed)

There are no exclusion criteria for the Long Term Extension Cohort .
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Artificial Iris (CustomFlex)	Device	Compassionate Use Cohort, Continued Access Cohort, PMA Cohort

Primary outcome

Changes in Symptoms
Time frame: SCR & 6 Month
Quality of vision will be assessed using the National Eye Institute Visual Functioning Questionnaire - 25.
Participant Satisfaction
Time frame: SCR & 6 Month
Participant satisfaction will be assessed using the Global Aesthetic Improvement Scale.
Complications and Adverse Events
Time frame: 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.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Barbara Fant contact

513-961-8200

bsfant@crc-regulatory.com

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Artificial Iris (CustomFlex) in people with Full Aniridia and Partial Aniridia, run by Clinical Research Consultants, Inc. at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Barbara Fant (513-961-8200, bsfant@crc-regulatory.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Symptoms (time frame: SCR & 6 Month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01860612.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022.