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

October 2013

Estimated Completion Date

April 2017


  • Device: Artificial Iris (CustomFlex)


  • Ophthalmology: Cornea/Anterior Segment,Uveitis
  • Physician Assistant: Ophthalmology

MeSH Terms

  • Artificial Iris
  • Full Iris Defects
  • Iris Defects
  • Partial Aniridia

Study ID

HumanOptics AG -- AI-001



Trial ID


Study Type


Trial Phase

Phase 3

Enrollment Quota



HumanOptics AG

Inclusion 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.

Exclusion Criteria

    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 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. 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)

Study Location Distance Name Phone Email
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 Butcher 516-504-9361
The Mackool Eye Institute - Astoria, New York 183.0 miles Fianmy Guzman 718-728-3400
Wills Eye Institute - Philadelphia, Pennsylvania 269.5 miles Irene Spanelis 877-289-4557
Cincinnati Eye Institute - Cincinnati, Ohio 726.5 miles Amy Jost 513-984-5133
Price Vision Group - Indianapolis, Indiana 804.1 miles Kathey Kelley OD 317-844-5530
Woolfson Eye Institute - Atlanta, Georgia 927.9 miles Jodi Miller 770-804-1684
Eye Consultants of Atlanta - Atlanta, Georgia 934.9 miles Teresa Long 404-351-2220
Minnesota Eye Consultants - Bloomington, Minnesota 1,123.6 miles Lindsay Fallenstein 801-581-2352
Alkek Eye Center Baylor College of Medicine - Houston, Texas 1,609.9 miles Margaret Olfson 713-798-4125
The Eye Institute of Utah - Salt Lake City, Utah 2,098.3 miles Karen Bachman 801-581-2352
Oregon Eye Associates - Eugene, Oregon 2,581.7 miles None None None
Advanced Vision Care - Los Angeles, California 2,603.8 miles Ann McLean 310-229-1220
Jules Stein Eye Institute - Los Angeles, California 2,605.2 miles Christine Jorgensen 310-206-1634 provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.