The Eye Institute of Utah | Salt Lake City, UT
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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.
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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:
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":
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:
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:
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:
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 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.
Primary purpose
Allocation
Interventional model
Masking
500 participants in 3 patient groups
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Central trial contact
Barbara Fant
Data sourced from clinicaltrials.gov
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