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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Clinical Research Consultants, Inc.
HumanOptics AG
Information provided by (Responsible Party):
Clinical Research Consultants, Inc. Identifier:
First received: May 20, 2013
Last updated: January 26, 2015
Last verified: January 2015
The purpose of this study is to evaluate the safety and effectiveness of an artificial iris prosthesis for the treatment of iris defects.

Condition Intervention Phase
Full Aniridia
Partial Aniridia
Device: Artificial Iris (CustomFlex)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of the CustomFlex Artificial Iris Prosthesis for the Treatment of Iris Defects

Resource links provided by NLM:

Further study details as provided by Clinical Research Consultants, Inc.:

Primary Outcome Measures:
  • Changes in Symptoms [ Time Frame: SCR & 6 Month ] [ Designated as safety issue: No ]
    Quality of vision will be assessed using the National Eye Institute Visual Functioning Questionnaire - 25.

  • Participant Satisfaction [ Time Frame: SCR & 6 Month ] [ Designated as safety issue: No ]
    Participant satisfaction will be assessed using the Global Aesthetic Improvement Scale.

  • Complications and Adverse Events [ Time Frame: SCR & 6 Month ] [ Designated as safety issue: Yes ]
    Complications and adverse events will be assessed through tabulation of adverse events, changes in vision, cell density, intraocular pressure, and slit lamp exam.

Estimated Enrollment: 300
Study Start Date: October 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PMA Cohort
The artificial iris will be implanted in the eye with an iris defect. The fellow eye can be treated 1 month after the primary eye.
Device: Artificial Iris (CustomFlex)
Experimental: Compassionate Use Cohort
Study participants that do not meet the inclusion/exclusion criteria for the study may be enrolled in the compassionate use treatment arm. The artificial iris will be implanted in the eye with an iris defect. The fellow eye can be treated 1 month after the primary eye.
Device: Artificial Iris (CustomFlex)


Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01860612

Contact: Barbara Fant 513-961-8200

United States, California
Advanced Vision Care Recruiting
Los Angeles, California, United States, 90067
Contact: Ann McLean    310-229-1220   
Principal Investigator: Samuel Masket, M.D.         
Jules Stein Eye Institute Recruiting
Los Angeles, California, United States, 90095
Contact: Christine Jorgensen    310-206-1634   
Principal Investigator: Kevin Miller, M.D.         
United States, Georgia
Woolfson Eye Institute Recruiting
Atlanta, Georgia, United States, 30328
Contact: Jodi Miller    770-804-1684   
Principal Investigator: R. Doyle Stulting, Ph.D. M.D.         
Eye Consultants of Atlanta Recruiting
Atlanta, Georgia, United States, 30339
Contact: Teresa Long    404-351-2220 ext 1285   
Principal Investigator: Stephen Hamilton, MD         
United States, Indiana
Price Vision Group Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Kathey Kelley, O.D.    317-844-5530   
Principal Investigator: Francis Price, M.D.         
United States, Massachusetts
Massachusetts Eye and Ear Infirmary Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Brian Vatcher       Brian_Vatcher@MEEI.HARVARD.EDU   
Principal Investigator: Roberto Pineda, M.D.         
United States, Minnesota
Minnesota Eye Consultants Recruiting
Bloomington, Minnesota, United States, 55431
Contact: Lindsay Fallenstein    801-581-2352   
Principal Investigator: David Hardten, M.D.         
United States, New York
Rosenthal Eye Surgery Active, not recruiting
Great Neck, New York, United States, 11023
United States, Ohio
Cincinnati Eye Institute Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Amy Jost    513-984-5133   
Principal Investigator: Michael Snyder, M.D.         
United States, Oregon
Oregon Eye Associates Active, not recruiting
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Wills Eye Institute Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Irene Spanelis    877-289-4557   
Principal Investigator: Brandon Ayres, M.D.         
United States, Texas
Alkek Eye Center/ Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Margaret Olfson    713-798-4125   
Principal Investigator: Doug Koch, M.D.         
United States, Utah
The Eye Institute of Utah Recruiting
Salt Lake City, Utah, United States, 84107
Contact: Karen Bachman    801-581-2352   
Principal Investigator: Robert Cionni, M.D.         
Sponsors and Collaborators
Clinical Research Consultants, Inc.
HumanOptics AG
  More Information

No publications provided

Responsible Party: Clinical Research Consultants, Inc. Identifier: NCT01860612     History of Changes
Other Study ID Numbers: AI-001
Study First Received: May 20, 2013
Last Updated: January 26, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Congenital Abnormalities
Eye Abnormalities
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Iris Diseases
Uveal Diseases processed this record on November 30, 2015