RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2013-10

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT01860612

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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. 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. 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.	1. Uncontrolled ocular inflammation (e.g., uveitis). 2. Preoperative intraocular pressure \> 21 mm Hg. 3. Subjects with a current condition that, in the investigator's opinion, would interfere with the treatment. 4. Subjects with any of the following conditions: 1. Severe chronic uveitis 2. Microphthalmus 3. Untreated retinal detachment 4. Untreated chronic glaucoma 5. Rubella cataract 6. Rubeosis of the iris 7. Proliferative diabetic retinopathy 5. Female subjects who are pregnant or lactating at the time of surgery. 6. Subjects with a known sensitivity to required postoperative study medications (4th generation fluoroquinolone or steroid anti-inflammatory) if an alternative medication is not available. 7. Subjects under legal guardianship or who, in the investigator's opinion, lack the mental capacity to provide written informed consent for study participation. 8. Stargardt's retinopathy. 9. Subjects with gastric ulcers or diabetes mellitus in whom high doses of postoperative systemic steroids are required. 10. Surgical difficulty of the planned surgery, which might increase the potential for complications. 11. No useful vision or vision potential in the fellow eye. 12. Clear crystalline lens (in eyes with intact natural, crystalline lens). 13. Implantation of a CustomFlex™ Artificial Iris prosthesis in the contralateral eye within the previous 4 weeks. 14. 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. 1. Uncontrolled ocular inflammation (e.g., uveitis). 2. Preoperative intraocular pressure \> 21 mm Hg. 3. Subjects with a current condition that, in the investigator's opinion, would interfere with the treatment. 4. Subjects with any of the following conditions: 1. Severe chronic uveitis 2. Microphthalmus 3. Untreated retinal detachment 4. Untreated chronic glaucoma 5. Rubella cataract 6. Rubeosis of the iris 7. Proliferative diabetic retinopathy 8. Intraocular infections 5. Severe endothelial corneal dystrophy. 6. 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. 7. Female subjects who are pregnant or lactating at the time of surgery. 8. Subjects with a known sensitivity to required postoperative study medications (4th generation fluoroquinolone or steroid anti-inflammatory) if an alternative medication is not available. 9. Subjects under legal guardianship or who, in the investigator's opinion, lack the mental capacity to provide written informed consent for study participation. 10. Stargardt's retinopathy. 11. Subjects with gastric ulcers or diabetes mellitus in whom high doses of postoperative systemic steroids are required. 12. Surgical difficulty of the planned surgery, which might increase the potential for complications. 13. No useful vision or vision potential in the fellow eye. 14. Clear crystalline lens (in eyes with intact natural, crystalline lens). 15. Implantation of a CustomFlex™ Artificial Iris prosthesis in the contralateral eye within the previous 4 weeks. 16. 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.

Inclusion Criteria

Exclusion Criteria

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.
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.
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.

1. Uncontrolled ocular inflammation (e.g., uveitis).
2. Preoperative intraocular pressure \> 21 mm Hg.
3. Subjects with a current condition that, in the investigator's opinion, would interfere with the treatment.
4. Subjects with any of the following conditions:
1. Severe chronic uveitis
2. Microphthalmus
3. Untreated retinal detachment
4. Untreated chronic glaucoma
5. Rubella cataract
6. Rubeosis of the iris
7. Proliferative diabetic retinopathy
5. Female subjects who are pregnant or lactating at the time of surgery.
6. Subjects with a known sensitivity to required postoperative study medications (4th generation fluoroquinolone or steroid anti-inflammatory) if an alternative medication is not available.
7. Subjects under legal guardianship or who, in the investigator's opinion, lack the mental capacity to provide written informed consent for study participation.
8. Stargardt's retinopathy.
9. Subjects with gastric ulcers or diabetes mellitus in whom high doses of postoperative systemic steroids are required.
10. Surgical difficulty of the planned surgery, which might increase the potential for complications.
11. No useful vision or vision potential in the fellow eye.
12. Clear crystalline lens (in eyes with intact natural, crystalline lens).
13. Implantation of a CustomFlex™ Artificial Iris prosthesis in the contralateral eye within the previous 4 weeks.
14. 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.
1. Uncontrolled ocular inflammation (e.g., uveitis).
2. Preoperative intraocular pressure \> 21 mm Hg.
3. Subjects with a current condition that, in the investigator's opinion, would interfere with the treatment.
4. Subjects with any of the following conditions:
1. Severe chronic uveitis
2. Microphthalmus
3. Untreated retinal detachment
4. Untreated chronic glaucoma
5. Rubella cataract
6. Rubeosis of the iris
7. Proliferative diabetic retinopathy
8. Intraocular infections
5. Severe endothelial corneal dystrophy.
6. 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.
7. Female subjects who are pregnant or lactating at the time of surgery.
8. Subjects with a known sensitivity to required postoperative study medications (4th generation fluoroquinolone or steroid anti-inflammatory) if an alternative medication is not available.
9. Subjects under legal guardianship or who, in the investigator's opinion, lack the mental capacity to provide written informed consent for study participation.
10. Stargardt's retinopathy.
11. Subjects with gastric ulcers or diabetes mellitus in whom high doses of postoperative systemic steroids are required.
12. Surgical difficulty of the planned surgery, which might increase the potential for complications.
13. No useful vision or vision potential in the fellow eye.
14. Clear crystalline lens (in eyes with intact natural, crystalline lens).
15. Implantation of a CustomFlex™ Artificial Iris prosthesis in the contralateral eye within the previous 4 weeks.
16. 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.

Contacts and Locations

Study Contact

Barbara Fant

CONTACT

513-961-8200

bsfant@crc-regulatory.com

Study Locations (Sites)

Advanced Vision Care

Los Angeles, California, 90067

United States

Jules Stein Eye Institute

Los Angeles, California, 90095

United States

Woolfson Eye Institute

Atlanta, Georgia, 30328

United States

Eye Consultants of Atlanta

Atlanta, Georgia, 30339

United States

Price Vision Group

Indianapolis, Indiana, 46260

United States

Minnesota Eye Consultants

Bloomington, Minnesota, 55431

United States

The Mackool Eye Institute

Astoria, New York, 11103

United States

Rosenthal Eye Surgery

Great Neck, New York, 11023

United States

Cincinnati Eye Institute

Cincinnati, Ohio, 45242

United States

Oregon Eye Associates

Eugene, Oregon, 97401

United States

Wills Eye Institute

Philadelphia, Pennsylvania, 19107

United States

Alkek Eye Center/ Baylor College of Medicine

Houston, Texas, 77030

United States

The Eye Institute of Utah

Salt Lake City, Utah, 84107

United States

Collaborators and Investigators

Sponsor: Clinical Research Consultants, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2013-10

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2013-10

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

Full Aniridia
Partial Aniridia