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

• Sponsor: Clinical Research Consultants, Inc. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT01860612
• Collaborator: HumanOptics AG (Industry)
• Enrollment: 580
• Locations: 12
• Arms: 3
• Duration (Months): 68
• Patients Per Site: 48.3
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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)	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Oct 1, 2013
• Anticipated Primary Completion Date: Jun 1, 2019
• Anticipated Study Completion Date: Jun 1, 2019

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Changes in Symptoms [SCR & 6 Month]

   Quality of vision will be assessed using the National Eye Institute Visual Functioning Questionnaire - 25.

2. Participant Satisfaction [SCR & 6 Month]

   Participant satisfaction will be assessed using the Global Aesthetic Improvement Scale.

3. Complications and Adverse Events [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• 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:

5. Severe chronic uveitis

6. Microphthalmus

7. Untreated retinal detachment

8. Untreated chronic glaucoma

9. Rubella cataract

10. Rubeosis of the iris

11. Proliferative diabetic retinopathy

12. Female subjects who are pregnant or lactating at the time of surgery.

13. Subjects with a known sensitivity to required postoperative study medications (4th generation fluoroquinolone or steroid anti-inflammatory) if an alternative medication is not available.

14. Subjects under legal guardianship or who, in the investigator's opinion, lack the mental capacity to provide written informed consent for study participation.

15. Stargardt's retinopathy.

16. Subjects with gastric ulcers or diabetes mellitus in whom high doses of postoperative steroids are required.

17. Surgical difficulty of the planned surgery, which might increase the potential for complications.

18. No useful vision or vision potential in the fellow eye.

19. Clear crystalline lens.

20. Implantation of a CustomFlex Artificial Iris prosthesis in the contralateral eye within the previous 4 weeks.

21. 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

Locations

	Site	City	State	Country	Postal Code
1	Advanced Vision Care	Los Angeles	California	United States	90067
2	Jules Stein Eye Institute	Los Angeles	California	United States	90095
3	Eye Consultants of Atlanta	Atlanta	Georgia	United States	30339
4	Price Vision Group	Indianapolis	Indiana	United States	46260
5	Minnesota Eye Consultants	Bloomington	Minnesota	United States	55431
6	The Mackool Eye Institute	Astoria	New York	United States	11103
7	Rosenthal Eye Surgery	Great Neck	New York	United States	11023
8	Cincinnati Eye Institute	Cincinnati	Ohio	United States	45242
9	Oregon Eye Associates	Eugene	Oregon	United States	97401
10	Wills Eye Institute	Philadelphia	Pennsylvania	United States	19107
11	Alkek Eye Center/ Baylor College of Medicine	Houston	Texas	United States	77030
12	The Eye Institute of Utah	Salt Lake City	Utah	United States	84107

Sponsors and Collaborators

• Clinical Research Consultants, Inc.
• HumanOptics AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Clinical Research Consultants, Inc.
• ClinicalTrials.gov Identifier: NCT01860612
• Other Study ID Numbers: AI-001
• First Posted: May 23, 2013
• Last Update Posted: Nov 26, 2018
• Last Verified: Nov 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Aniridia

Study Results

No Results Posted as of Nov 26, 2018