Safety and Effectiveness of the CustomFlex Artificial Iris Prosthesis for the Treatment of Iris Defects
The purpose of this study is to evaluate the safety and effectiveness of an artificial iris prosthesis for the treatment of iris defects.
Study Start Date
Estimated Completion Date
- Device: Artificial Iris (CustomFlex)
- Ophthalmology: Cornea/Anterior Segment,Uveitis
- Physician Assistant: Ophthalmology
- Artificial Iris
- Full Iris Defects
- Iris Defects
- Partial Aniridia
HumanOptics AG -- AI-001
1. 22 years of age or older
2. Having a diagnosis of congenital or acquired full or partial iris defect in the study
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
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
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
steroids are required.
10. Surgical difficulty of the planned surgery, which might increase the potential for
11. No useful vision or vision potential in the fellow eye.
12. Clear 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.
22 Years and older
Accepts Healthy Volunteers
Study Locations and Contact Information (14)
|Massachusetts Eye and Ear Infirmary - Boston, Massachusetts||2.8 miles||Brian Vatcher||None||Brian_Vatcher@MEEI.HARVARD.EDU|
|Rosenthal Eye Surgery - Great Neck, New York||174.2 miles||Jennifer Butcherfirstname.lastname@example.org|
|The Mackool Eye Institute - Astoria, New York||183.0 miles||Fianmy Guzmanemail@example.com|
|Wills Eye Institute - Philadelphia, Pennsylvania||269.5 miles||Irene Spanelis||877-289-4557||Ispanelis@oppdoctors.com|
|Cincinnati Eye Institute - Cincinnati, Ohio||726.5 miles||Amy Jostfirstname.lastname@example.org|
|Price Vision Group - Indianapolis, Indiana||804.1 miles||Kathey Kelley ODemail@example.com|
|Woolfson Eye Institute - Atlanta, Georgia||927.9 miles||Jodi Miller||770-804-1684||JMiller@woolfsoneye.com|
|Eye Consultants of Atlanta - Atlanta, Georgia||934.9 miles||Teresa Longfirstname.lastname@example.org|
|Minnesota Eye Consultants - Bloomington, Minnesota||1,123.6 miles||Lindsay Fallensteinemail@example.com|
|Alkek Eye Center Baylor College of Medicine - Houston, Texas||1,609.9 miles||Margaret Olfsonfirstname.lastname@example.org|
|The Eye Institute of Utah - Salt Lake City, Utah||2,098.3 miles||Karen Bachmanemail@example.com|
|Oregon Eye Associates - Eugene, Oregon||2,581.7 miles||None||None||None|
|Advanced Vision Care - Los Angeles, California||2,603.8 miles||Ann McLeanfirstname.lastname@example.org|
|Jules Stein Eye Institute - Los Angeles, California||2,605.2 miles||Christine Jorgensen||310-206-1634||Jorgensen@jsei.ucla.edu|