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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01860612
Recruitment Status : Recruiting
First Posted : May 23, 2013
Last Update Posted : October 24, 2022
Sponsor:
Collaborator:
HumanOptics AG
Information provided by (Responsible Party):
Clinical Research Consultants, Inc.

Brief Summary:
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.

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 : 500 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 : December 31, 2025
Estimated Study Completion Date : December 31, 2025

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

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:

  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.

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":

  1. Previous AI-001 IDE study participant who was enrolled before PMA approval (i.e., before May 30, 2018) and has had the CustomFlex™ Artificial Iris implanted for 36 months or less if enrolled as an adult or for 60 months or less if enrolled as a pediatric subject.
  2. Signed and received a copy of the signed written informed consent.
  3. Willingness and ability to comply with schedule for follow-up visits and postoperative evaluations.

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:

  1. Age between 3 years and less than 22 years at the time of consent for the OSB PAS.
  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 or other aniridic symptoms 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 for the OSB PAS.
  6. Willingness and ability to comply with schedule for follow-up visits and postoperative evaluations.

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:

  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 systemic 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 (in eyes with intact natural, 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.

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:

  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
    8. Intraocular infections
  5. Severe endothelial corneal dystrophy.
  6. 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.
  7. Female subjects who are pregnant or lactating at the time of surgery.
  8. Subjects with a known sensitivity to required postoperative study medications (4th generation fluoroquinolone or steroid anti-inflammatory) if an alternative medication is not available.
  9. Subjects under legal guardianship or who, in the investigator's opinion, lack the mental capacity to provide written informed consent for study participation.
  10. Stargardt's retinopathy.
  11. Subjects with gastric ulcers or diabetes mellitus in whom high doses of postoperative systemic steroids are required.
  12. Surgical difficulty of the planned surgery, which might increase the potential for complications.
  13. No useful vision or vision potential in the fellow eye.
  14. Clear crystalline lens (in eyes with intact natural, crystalline lens).
  15. Implantation of a CustomFlex™ Artificial Iris prosthesis in the contralateral eye within the previous 4 weeks.
  16. 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


Contacts
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Contact: Barbara Fant 513-961-8200 bsfant@crc-regulatory.com

Locations
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United States, California
Advanced Vision Care Recruiting
Los Angeles, California, United States, 90067
Contact: Ory Shiler    310-229-1220    orlyjr@inorbit.com   
Principal Investigator: Nicole Fram, M.D.         
Jules Stein Eye Institute Completed
Los Angeles, California, United States, 90095
United States, Georgia
Woolfson Eye Institute Withdrawn
Atlanta, Georgia, United States, 30328
Eye Consultants of Atlanta Completed
Atlanta, Georgia, United States, 30339
United States, Indiana
Price Vision Group Completed
Indianapolis, Indiana, United States, 46260
United States, Minnesota
Minnesota Eye Consultants Active, not recruiting
Bloomington, Minnesota, United States, 55431
United States, New York
The Mackool Eye Institute Completed
Astoria, New York, United States, 11103
Rosenthal Eye Surgery Completed
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    ajost@cincinnatieye.com   
Principal Investigator: Michael Snyder, M.D.         
United States, Oregon
Oregon Eye Associates Completed
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Wills Eye Institute Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Gwen Toti    877-289-4557    gtoti@oppdoctors.com   
Principal Investigator: Brandon Ayres, M.D.         
United States, Texas
Alkek Eye Center/ Baylor College of Medicine Completed
Houston, Texas, United States, 77030
United States, Utah
The Eye Institute of Utah Completed
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: October 24, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: 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