UnknownNot Applicable

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

United States500 participantsStarted 2013-10

Plain-language 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.

Age range3 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 22 years of age or older
✓. Having a diagnosis of congenital or acquired full or partial iris defect in the study eye.
✓. Having symptoms of light sensitivity, photophobia, and/or glare in the study eye.
✓. Subjects should be pseudophakic, aphakic or require cataract extraction.
✓. Signed and received a copy of the signed written informed consent.
✓. Willingness and ability to comply with schedule for follow-up visits and postoperative evaluations.
✓. 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.
✓. Signed and received a copy of the signed written informed consent.

✕. Uncontrolled ocular inflammation (e.g., uveitis).
✕. Preoperative intraocular pressure \> 21 mm Hg.
✕. Subjects with a current condition that, in the investigator's opinion, would interfere with the treatment.
✕. Subjects with any of the following conditions:
✕. Severe chronic uveitis
✕. Microphthalmus
✕. Untreated retinal detachment
✕. Untreated chronic glaucoma

Changes in Symptoms

Timeframe: SCR & 6 Month

Participant Satisfaction

Timeframe: SCR & 6 Month

Complications and Adverse Events

Timeframe: SCR & 6 Month

NCT IDNCT01860612

SponsorClinical Research Consultants, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-31

Barbara Fant

Who can participate

Age range3 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 22 years of age or older
✓. Having a diagnosis of congenital or acquired full or partial iris defect in the study eye.
✓. Having symptoms of light sensitivity, photophobia, and/or glare in the study eye.
✓. Subjects should be pseudophakic, aphakic or require cataract extraction.
✓. Signed and received a copy of the signed written informed consent.
✓. Willingness and ability to comply with schedule for follow-up visits and postoperative evaluations.
✓. 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.
✓. Signed and received a copy of the signed written informed consent.

✕. Uncontrolled ocular inflammation (e.g., uveitis).
✕. Preoperative intraocular pressure \> 21 mm Hg.
✕. Subjects with a current condition that, in the investigator's opinion, would interfere with the treatment.
✕. Subjects with any of the following conditions:
✕. Severe chronic uveitis
✕. Microphthalmus
✕. Untreated retinal detachment
✕. Untreated chronic glaucoma