Clinical Evaluation of Morcher Artificial Iris Diaphragms

Aniridia is a condition in which the iris, the colored portion of the eye, is either
partially or completely absent. The iris is responsible for regulating the amount of light
entering the eye by adjusting the size of the pupil.

Aniridia can either be a congenital condition, often a genetically-based abnormality
affecting the formation of the iris, or it can be acquired by blunt trauma with or without
rupture, penetrating trauma, or severe intraocular inflammation.

Aniridia can also vary in the level of severity. A mild case might involve a thinner iris or
iris remnant with a normal pupil. A severe case might involve complete absence of the iris or
impairment of the muscles responsible for adjusting pupil size.

Iris defects can occur without the loss of stromal tissue as well. In some cases, the iris
pigment epithelium is missing. In other cases, holes are present in the iris or the pupil is
chronically enlarged or mydriatic.

People who suffer from iris defects also commonly suffer from other eye conditions. Common
comorbidities include glaucoma, cataract, and nystagmus. Other structures in the eye are
often affected, including the cornea, crystalline lens, zonules, and retina. Iris defects can
cause severe visual disability if untreated.

Common treatments for iris defects include the use of colored or tinted glasses or contact
lenses to reduce the amount of light entering the eye.

In this trial, several Morcher iris diaphragms are being evaluated as a potential treatment
to improve the symptoms associated with aniridia and other iris defects. Morcher iris
diaphragms are manufactured in Germany by Morcher GmbH [website: http:// www.morcher.com].
These devices have been utilized in Europe to treat aniridic patients for over 40 years.
Additionally, these devices hold the European CE mark of conformity.

When a patient is implanted with a Morcher iris device, surgery always involves additional
standard of care surgical procedures. Typically, a device is implanted during cataract
surgery along with an intraocular lens (IOL). Morcher devices can also be implanted during an
IOL exchange with or without an anterior vitrectomy. All implantation procedures take place
in an operating room under local or general anesthesia. In some cases, a Morcher iris
reconstruction lens containing both an artificial iris and a lens is implanted. Also,
depending on the condition of the eye, the lens and iris device may need to be sutured to the
sclera, the white portion of the eye.

All patients undergoing surgery are prescribed 2 different eye drops, an antibiotic and a
corticosteroid. These medications are used for up to 6 weeks following implantation of the
device. There are 5 postoperative follow-up visits that each patient must complete. Visits
occur at specific intervals over the course of a 1-year period. At each visit, standard of
care procedures are performed and, at certain time points during the follow-up interval,
digital photos and endothelial cell counts are obtained. In instances where both eyes are
implanted, surgery for the second eye is scheduled 6 months or more later.

Inclusion Criteria:

- Patient must be 18 years old and have partial or complete aniridia.

- Be willing and able to comply with all follow-up requirements.

- Must have increased light and/or glare sensitivity or complete aniridia.

- Patients may be phakic, aphakic, or pseudophakic.

- Phakic patients will require simultaneous cataract surgery.

- Aphakic patients will require secondary intraocular lens implantation.

Exclusion Criteria:

- The presence of any ocular condition that may cause complications from the surgical
procedure

- Active ocular infection or inflammation

- Patients with allergies to operative and/or postoperative medications

- Pregnant or lactating women

- Persons who, in the determination of the investigator, are not competent to understand
the procedure or the actions asked of them as research subjects