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

• Change from baseline in best-corrected glare visual acuity (BCGVA) at 3 months [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
  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.
  
  

• Reduction of 15% or more of the central endothelial cell density is considered an adverse safety event [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  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 ] [ Designated as safety issue: Yes ]
  
• Change from baseline in best-corrected visual acuity (BCVA) at 2 weeks [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: Yes ]
  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 ] [ Designated as safety issue: Yes ]
  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 ] [ Designated as safety issue: Yes ]
  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 ] [ Designated as safety issue: Yes ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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.
  
  

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 standard of care surgical procedures, which include cataract surgery with intraocular lens (IOL) implantation, IOL exchange, and/or anterior vitrectomy. These procedures are performed in an operating room under local or general anesthesia. The IOL and the iris diaphragm are placed into the eye through an incision in the cornea. The IOL is placed in the eye behind the normal position of the iris, inside the lens capsule if it remains following cataract removal. The iris diaphragm is placed in front of the IOL. In some cases a single-piece iris reconstruction lens containing an artificial iris and lens is implanted. If the capsule can not support an IOL and iris implant, they are sutured in place through the sclera, the white part of the eye. Two different medication eye drops are used for 4 to 6 weeks following surgery. Patients are required to return for 5 postoperative visits at intervals of 1 day, 2 weeks, 3, 6, and 12 months. Standard testing occurs at each of these visits and require approximately 1 to 2 hours of the patient's time. Color photographs of the eye and endothelial cell counts are obtained preoperatively and 3 months postoperatively. If required, the same procedure for the other eye may be performed 6 months after first eye surgery.

61 patients have been enrolled as of August 2012.