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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01860612
Recruitment Status : Active, not recruiting
First Posted : May 23, 2013
Last Update Posted : November 26, 2018
Sponsor:
Collaborator:
HumanOptics AG
Information provided by (Responsible Party):
Clinical Research Consultants, Inc.

Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of an artificial iris prosthesis for the treatment of iris defects.

Condition or disease Intervention/treatment Phase
Full Aniridia Partial Aniridia Device: Artificial Iris (CustomFlex) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 580 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of the CustomFlex Artificial Iris Prosthesis for the Treatment of Iris Defects
Study Start Date : October 2013
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Arm Intervention/treatment
Experimental: PMA Cohort
Study participants that 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)
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)
Experimental: Continued Access Cohort
Study participants that meet the inclusion/exclusion criteria for the study may be enrolled in the Continued Access cohort, after enrollment in the PMA cohort is complete.The fellow eye can be treated 1 month after the primary eye.
Device: Artificial Iris (CustomFlex)



Primary Outcome Measures :
  1. Changes in Symptoms [ Time Frame: SCR & 6 Month ]
    Quality of vision will be assessed using the National Eye Institute Visual Functioning Questionnaire - 25.

  2. Participant Satisfaction [ Time Frame: SCR & 6 Month ]
    Participant satisfaction will be assessed using the Global Aesthetic Improvement Scale.

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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01860612


Locations
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United States, California
Advanced Vision Care
Los Angeles, California, United States, 90067
Jules Stein Eye Institute
Los Angeles, California, United States, 90095
United States, Georgia
Eye Consultants of Atlanta
Atlanta, Georgia, United States, 30339
United States, Indiana
Price Vision Group
Indianapolis, Indiana, United States, 46260
United States, Minnesota
Minnesota Eye Consultants
Bloomington, Minnesota, United States, 55431
United States, New York
The Mackool Eye Institute
Astoria, New York, United States, 11103
Rosenthal Eye Surgery
Great Neck, New York, United States, 11023
United States, Ohio
Cincinnati Eye Institute
Cincinnati, Ohio, United States, 45242
United States, Oregon
Oregon Eye Associates
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Alkek Eye Center/ Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Utah
The Eye Institute of Utah
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Clinical Research Consultants, Inc.
HumanOptics AG

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Responsible Party: Clinical Research Consultants, Inc.
ClinicalTrials.gov Identifier: NCT01860612    
Other Study ID Numbers: AI-001
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Aniridia
Eye Abnormalities
Eye Diseases
Eye Diseases, Hereditary
Iris Diseases
Uveal Diseases
Congenital Abnormalities
Genetic Diseases, Inborn