Clinical Trial: Morcher Artificial Iris Devices to Treat Light and Glare Sensitivity in Partial or Complete Aniridia

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Compassionate Use Study of Morcher Artificial Iris Devices to Treat Light and Glare Sensitivity in Partial or Complete Aniridia

Brief Summary: The purpose of this study is to determine the safety and effectiveness of Morcher artificial iris devices in the treatment of congenital and acquired aniridia.

Detailed Summary:

Congenital aniridia is a rare genetic condition that results in the abnormal development of the iris (colored part) of the eye. This genetically inherited disorder occurs in approximately 1/60,000 to 1/100,000 births. Severe cases can result in the complete absence of the iris and the muscles that open and close the pupil. Mild cases can result in a thinner iris with a normal pupil. About half of the people with this condition also develop early cataracts that need to be removed in their 20's or 30's. Most have glaucoma, which is difficult to control. Vision is usually decreased by significant glare because the iris is not present to control the amount of light entering the eye. Vision can also be limited because of the presents of cataracts, glaucoma, and a condition called nystagmus in which there are uncontrollable jerking eye movements. The only treatment for aniridia is the use of colored glasses or contact lenses with images of an iris painted on them to reduce the amount of light entering the eye.

Acquired aniridia is more common than congenital aniridia. Acquired aniridia may be partial or complete and may be caused by trauma or surgery. Often the cornea, lens, and/or retina are affected simultaneously, resulting in severe visual disability.

Morcher GmbH, a German company, manufactures the iris diaphragms. Their web site is http://www.morcher.com. Morcher artificial iris devices are designed to reduce the significant light and glare sensitivity that patients experience with aniridia. These devices have been used in Europe for over 20 years. They hold the European CE mark of conformity and have been certified through the Active Implantable Medical Device Directive (AIMDD) since 1994.

Implantation of a Morcher iris diaphragm is performed in association with other stan
Sponsor: University of California, Los Angeles

Current Primary Outcome: Change from baseline in best-corrected glare visual acuity (BCGVA) at 3 months [ Time Frame: Baseline and 3 months ]

Original Primary Outcome: Improvement in best-corrected glare visual acuity (BCGVA). An improvement of 2 lines or better on the Snellen eye chart under glare test conditions is considered a positive outcome. [ Time Frame: 2 weeks, 3, 6 and 12 months ]

Current Secondary Outcome:

• Reduction of 15% or more of the central endothelial cell density is considered an adverse safety event [ Time Frame: 3 months ]
  Endothelial cell count to measure cell density at 3 months post-operative status
• Need to explant or exchange the Morcher Iris Diaphragm [ Time Frame: 6 months ]
• Change from baseline in best-corrected visual acuity (BCVA) at 2 weeks [ Time Frame: Baseline and 2 weeks ]
  Visual Acuity test under non glare conditions for patients who undergo simultaneous cataract surgery. A 2-line improvement on the Snellen eye chart is considered a positive response.
• Change from baseline in best-corrected visual acuity (BCVA) at 3 months [ Time Frame: Baseline and 3 months ]
  Visual Acuity test under non-glare conditions for patients who undergo simultaneous cataract surgery. A 2-line improvement on the Snellen eye chart is considered a positive response.
• Change from baseline in best-corrected visual acuity (BCVA) at 6 months [ Time Frame: Baseline and 6 months ]
  Visual Acuity test under non glare conditions for patients who undergo simultaneous cataract surgery. A 2-line improvement on the Snellen eye chart is considered a positive response.
• Change from baseline in best-corrected visual acuity (BCVA) at 12 months [ Time Frame: Baseline and 12 months ]
  Visual Acuity test under non glare conditions for patients who undergo simultaneous cataract surgery. A 2-line improvement on the Snellen eye chart is considered a positive response.
• Change from baseline in best-corrected glare visual acuity (BCGVA) at 2 weeks [ Time Frame: Baseline and 2 weeks ]
  Clinical glare test to test glare sensitivity on visual acuity. An improvement of 2 lines or better on the Snellen eye chart under glare test conditions is considered a positive outcome.
• Change from baseline in best-corrected glare visual acuity (BCGVA) at 6 months [ Time Frame: Baseline and 6 months ]
  Clinical glare test to test glare sensitivity on visual acuity. An improvement of 2 lines or better on the Snellen eye chart under glare test conditions is considered a positive outcome.
• Change from baseline in best-corrected glare visual acuity (BCGVA) at 12 months [ Time Frame: Baseline and 12 months ]
  Clinical glare test to test glare sensitivity on visual acuity. An improvement of 2 lines or better on the Snellen eye chart under glare conditions is considered a positive outcome.

Original Secondary Outcome:

• Improvement in best-corrected visual acuity (BCVA). A 2-line improvement on the Snellen eye chart under non-glare test conditions for patients who undergo simultaneous cataract surgery is considered a positive response. [ Time Frame: 2 weeks, 3, 6 and 12 months ]
• A 15% or greater reduction in central endothelial cell density is considered an adverse safety event. [ Time Frame: 3 months ]
• Need to explant or exchange the Morcher Iris Diaphragm [ Time Frame: 1 day, 2 weeks, 3, 6 and 12 months ]

Information By: University of California, Los Angeles

Dates:
Date Received: December 19, 2008
Date Started: September 2002
Date Completion: December 2030
Last Updated: May 26, 2015
Last Verified: May 2015