CORNEAL OPACITY WITH POOR PROGNOSIS FOR CORNEAL TRANSPLANT Clinical Trial
Official title:
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)
;