A Prospective, Multi-Center, Early Feasibility Study to Assess Clinical Outcomes of the GORE Synthetic Cornea Device in Patients With Loss of Corneal Clarity
Study objective is to evaluate the initial safety and effectiveness of the GORE Synthetic Cornea Device in the treatment of loss of corneal clarity in patients who are candidates for corneal transplantation
• Patients must meet all of the following criteria to be eligible to be consented for this study.
‣ Patient must be able to comprehend the study requirements and provide written informed consent. Patients must be willing to follow study instructions, agree to comply with all study procedures , and able to return for all scheduled follow-up examinations for 12 months postoperatively (the study duration). The follow-up exams may be extended up to 60 months post operatively if the patient consents to the extension.
⁃ Male or female patients ≥ 18 years old at the time of consent
⁃ Physical condition suitable for undergoing surgery, as evidenced by medical history and physical examination provided by a licensed medical provider (primary care physician, nurse practitioner, internal medicine physician etc.)
⁃ Currently with an opaque cornea (as determined by the investigator) with or without a prior history of failed donor corneal transplantation \[penetrating keratoplasty (PK) or endothelial keratoplasty (EK)\] and loss of corneal clarity
⁃ Best corrected distance visual acuity of worse than 20/400 in the study eye using Snellen chart
⁃ Best corrected distance visual acuity of better than 20/200 in the fellow (non-study) eye using Snellen chart
⁃ Pseudophakia status in the study eye with a stable posterior chamber intraocular lens (IOL) implant centered within the capsular bag or sulcus
⁃ Corneal thickness measurement in study eye (epithelium to endothelium; central and mid-peripheral/ 3 to 5mm away from center at superior, inferior, nasal and temporal quadrants) with each measurement between 700um - 900um, measured using ultrasound (US) pachymetry. If one or more measurements cannot be obtained using US pachymetry, measurements using anterior segment optical coherence tomography (OCT) may be used (with the measurement being between 700-900um)
⁃ If applicable, prior corneal transplant ≥ 8 mm in diameter
‣ Adequate lid function and normal ocular surface and tear film parameters for implant of the study device, as determined by the investigator.