SINGLE PATIENT EXPANDED ACCESS OF A PROSPECTIVE, MULTICENTER CLINICAL TRIAL DESIGNED TO EVALUATE THE SAFETY AND PROBABLE BENEFIT OF THE KERAKLEAR NON-PENETRATING KERATOPROSTHESIS IN SUBJECTS WITH CORNEAL OPACITY WITH POOR PROGNOSIS FOR CORNEAL TRANSPLANT
SINGLE PATIENT EXPANDED ACCESS OF A PROSPECTIVE, MULTICENTER CLINICAL TRIAL DESIGNED TO EVALUATE THE SAFETY AND PROBABLE BENEFIT OF THE KERAKLEAR NON-PENETRATING KERATOPROSTHESIS IN SUBJECTS WITH CORNEAL OPACITY WITH POOR PROGNOSIS FOR CORNEAL TRANSPLANT
This is for a "Single Patient Expanded Access" of an on-going study (IRB#2017-3526). In the
 on-going study, the maximum number of subject will be 35 subjects (35 eyes) will be implanted
 with the KeraKlear device and will be followed for one year. However, this expanded access is
 for single patient use below is a description of patient condition and circumstances
 necessitating treatment:

 88 year old female with 2 previous failed corneal transplants, had significant scarring and
 mild edema, surface well epithelialized, has potential for 10 letters of improvement in
 visual acuity. Patient is high risk for recurrent corneal rejection and failure and therefore
 would not be a candidate for standard corneal transplant. She would potentially do well with
 a partial thickness artificial cornea such as the KeraKlear.
For this "Single Patient Expanded Access" the research procedures will be based on the Master
 Protocol Version #1.2 dated 18Dec2017, with one foreseen deviation. Section 7.1 Page 27 under
 Inclusion Criteria #1 Male or female from 22 years to 80 years of age at screening study
 visit. This patient is 88 years old as of the submission of this Protocol Narrative to the
 IRB.

 Postoperatively, subject will be examined at (with window size in parentheses):

 -  1 Day (+2 days)

 -  1 Week (7±2 days)

 -  1 Month (30±5 days)

 -  2 Months (60±7 days)

 -  3 Months (90±7 days)

 -  4 Months (120±10 days)

 -  6 Months (180±10 days)

 -  9 Months (270±20 days)

 -  12 Months (360±20 days)
Inclusion Criteria:

 -  Corneal blindness where cornea transplantation is necessary but is expected to be
 unsuccessful due to severe limbal stem cell deficiency (LSCD) associated with aniridia
 or due to multiple (two or more) failed cornea transplantation surgeries and
 spontaneous visual improvement without surgical intervention is not expected or
 probable.

 -  Best Corrected Distance Visual Acuity (Snellen) which is equal or worse than 20/200 in
 the study eye (but at least light perception with projection)

 -  Estimated visual potential of the study eye is greater than or equal to at least two
 lines visual improvement of BCDVA of current vision in the study eye.

 Exclusion Criteria:

 -  Visual Acuity of No Light Perception (NLP) in the study eye

 -  The patient is monocular or the non-study eye has Best Corrected Distance Visual
 Acuity (Snellen) of worse than 20/160 due to an ocular condition other than severe
 aniridic limbal stem cell deficiency or due to multiple (two or more) failed cornea
 transplantation surgeries.

 -  Suitable for standard PK with donor tissue in the study eye.

 -  History of severe dry eye syndrome or a Schirmer test with results of less than 3mm
 after 5 minutes of testing with the use of topical anesthetic in either eye.

 -  Active or history of an auto-immune disease (e.g. Rheumatoid Arthritis, Ocular
 Cicatricial Pemphigoid, Lupus, Steven's Johnson Syndrome, atopic keratoconjunctivitis,
 etc.).

 -  On medications that may affect wound healing, such as antimetabolites or other
 chemotherapeutic agents.

 -  History of posterior segment eye disease in either eye (including macular
 degeneration, optic neuropathy, posterior uveitis) which is expected to limit the
 visual improvement to less than two lines of vision.

 -  History of retinal surgery in the fellow eye (including retinal detachment repair,
 intravitreal injection etc.).

 -  History of retinal surgery in the study eye (including retinal detachment repair,
 intravitreal injection, etc.) unless the vision is at least light perception with
 projection in four field quadrants and the macula is attached (if there is no view of
 the retina, an ultrasound must show the macula is attached).

 -  History of uncontrolled glaucoma in either eye (IOP has been measured above 25 mmHg at
 any time in the last 6 months).

 -  Current use of beta blocker eye drops (e.g. timolol, levobunolol, etc.).

 -  Vertical cup-to-disc (C:D) ratio greater than or equal to 0.8 in either eye (if able
 to visible through corneal opacity). If not visible, patient is not to be excluded.

 -  Limited visual potential (patient does not have the ability to improve a minimum of
 two lines of vision of BCDVA by history).

 -  History of amblyopia in the study eye limiting visual potential.

 -  If the patient has had a corneal transplant, corneal transplantation surgery was
 performed less than 2 years ago.

 -  Anticipated need for surgery on the study eye during the course of the study
 (including cataract surgery).

 -  Aphakia in the study eye.

 -  Active ocular infection in either eye.

 -  Hypotony in the study eye (IOP < 6mmHg).

 -  History of herpetic ocular infection in the study eye.

 -  Corneal thickness less than 400 microns in any region of the pachymetry map.

 -  Inability to protect the operated eye from trauma.

 -  Females who are pregnant, lactating, or unwilling to use adequate birth control for t
 the duration of the study.

 -  Patient is currently taking Sumatriptan (Imitrex) and unable to discontinue during the
 study.

 For this "Single Patient Expanded Access" the research procedures will be based on the
 Master Protocol Version #1.2 dated 18Dec2017, with one foreseen deviation. Section 7.1 Page
 27 under Inclusion Criteria #1 Male or female from 22 years to 80 years of age at screening
 study visit. This patient is 88 years old.

 -