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

Eligibility 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.