Using an artificial iris prosthesis to treat iris defects

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

This study tests if an artificial iris can help adults with iris defects feel more comfortable and improve their quality of life after cataract surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 3 Years and up
• Sex: All
• Sponsor: Clinical Research Consultants, Inc. (Industry-sponsored)
• Locations: 13 sites (Los Angeles, California and 12 other locations)
• Trial ID: NCT01860612 on ClinicalTrials.gov

What this trial studies

This study evaluates the long-term safety and effectiveness of the CustomFlex artificial iris prosthesis for individuals with full or partial iris defects. Participants will undergo implantation of the prosthesis and will be monitored for symptoms such as light sensitivity and glare. The study aims to determine how well the prosthesis improves visual comfort and quality of life for patients suffering from these conditions. Eligible participants include adults with specific iris defects who have previously undergone cataract surgery or are in need of cataract extraction.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 and older with congenital or acquired full or partial iris defects who experience symptoms like photophobia.

Not a fit: Patients who do not have iris defects or those who are not experiencing symptoms related to their iris condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with iris defects by reducing light sensitivity and enhancing visual comfort.

How similar studies have performed: While this approach is relatively novel, similar studies involving artificial implants for ocular conditions have shown promising results.

Eligibility criteria

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 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:

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.

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:

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.

Where this trial is running

Los Angeles, California and 12 other locations

• Advanced Vision Care — Los Angeles, California, United States (Recruiting)
• Jules Stein Eye Institute — Los Angeles, California, United States (Completed)
• Woolfson Eye Institute — Atlanta, Georgia, United States (Withdrawn)
• Eye Consultants of Atlanta — Atlanta, Georgia, United States (Completed)
• Price Vision Group — Indianapolis, Indiana, United States (Completed)
• Minnesota Eye Consultants — Bloomington, Minnesota, United States (Active_not_recruiting)
• The Mackool Eye Institute — Astoria, New York, United States (Completed)
• Rosenthal Eye Surgery — Great Neck, New York, United States (Completed)
• Cincinnati Eye Institute — Cincinnati, Ohio, United States (Recruiting)
• Oregon Eye Associates — Eugene, Oregon, United States (Completed)
• Wills Eye Institute — Philadelphia, Pennsylvania, United States (Recruiting)
• Alkek Eye Center/ Baylor College of Medicine — Houston, Texas, United States (Completed)
• The Eye Institute of Utah — Salt Lake City, Utah, United States (Completed)

Study contacts

• Study coordinator: Barbara Fant

Conditions Full Aniridia; Partial Aniridia