Clinical Outcomes of the Gore Synthetic Cornea Device

Key Inclusion Criteria:

• Patients must meet all of the following criteria to be eligible to be consented forthis study.

1. Patient must be able to comprehend the study requirements and provide writteninformed consent. Patients must be willing to follow study instructions, agreeto comply with all study procedures , and able to return for all scheduledfollow-up examinations for 12 months postoperatively (the study duration). Thefollow-up exams may be extended up to 60 months post operatively if the patientconsents to the extension.

2. Male or female patients ≥ 18 years old at the time of consent

3. Physical condition suitable for undergoing surgery, as evidenced by medicalhistory and physical examination provided by a licensed medical provider (primary care physician, nurse practitioner, internal medicine physician etc.)

4. Currently with an opaque cornea (as determined by the investigator) with orwithout a prior history of failed donor corneal transplantation [penetratingkeratoplasty (PK) or endothelial keratoplasty (EK)] and loss of corneal clarity

5. Best corrected distance visual acuity of worse than 20/400 in the study eyeusing Snellen chart

6. Best corrected distance visual acuity of better than 20/200 in the fellow (non-study) eye using Snellen chart

7. Pseudophakia status in the study eye with a stable posterior chamberintraocular lens (IOL) implant centered within the capsular bag or sulcus

8. Corneal thickness measurement in study eye (epithelium to endothelium; centraland mid-peripheral/ 3 to 5mm away from center at superior, inferior, nasal andtemporal quadrants) with each measurement between 700um - 900um, measured usingultrasound (US) pachymetry. If one or more measurements cannot be obtainedusing US pachymetry, measurements using anterior segment optical coherencetomography (OCT) may be used (with the measurement being between 700-900um)

9. If applicable, prior corneal transplant ≥ 8 mm in diameter

10. Adequate lid function and normal ocular surface and tear film parameters forimplant of the study device, as determined by the investigator.

Key Exclusion Criteria:

• Patients who meet any of the following exclusion criteria cannot be consented andincluded in this study:

1. Inability to provide written informed consent and comply with study assessmentsfor the full duration of the study.

2. Age: < 18 years

3. Patients who are pregnant/nursing or planning to become pregnant during thestudy.Note: For women of child-bearing potential, confirmation of pregnancy statusmust be documented per site standard.

4. Corneal thickness measurement (epithelium to endothelium; central andmid-peripheral/ 3 to 5mm away from center at superior, inferior, nasal andtemporal quadrants) in the study eye with any measurement less than 700um ormore than 900um measured using US pachymetry. If one or more measurementscannot be obtained using US pachymetry, measurements using anterior segment OCTmay be used

5. If applicable, prior corneal transplant < 8 mm in diameter

6. Aphakic or phakic status of the study eye

7. Pseudophakic status of the study eye with anterior chamber IOL or unstableposterior chamber IOL, according to clinical history or UBM

8. Evidence of tear film, ocular surface or lid abnormalities in the study eye

• Schirmer test without anesthesia less than 5 mm at 5 minutes. NOTE:Patient can be eligible after successful tear duct blockage (such as plugsor cauterization) if the Schirmer's are adequate following the procedure
• Evidence of conjunctival or lid margin keratinization
• Presence of cicatrizing conjunctivitis (Stevens Johnson Syndrome, mucousmembrane pemphigoid, trachoma, chemical, radiation or thermal trauma
• Prior history of stage II or III neurotrophic keratitis / keratopathy
• Limbal stem cell deficiency leading to prior episode(s) of recurrent orpersistent corneal epithelial defects
• Prior history of immune-mediated/ non-infectious keratolysis with orwithout underlying systemic disease
• Significant lid margin disease with infestation/infection within 30 daysprior to surgery.NOTE: Patient can be eligible after successful treatment and resolution
• Significant anatomical lid problems (trichiasis, entropion, ectropion,lagophthalmos, exophthalmos, Bell's palsy, or significant ptosis)

9. Current or history of corneal or ocular surface infection in the study eyewithin 30 days prior to surgery.NOTE: Patient can be eligible after successful treatment and resolution asdetermined by the investigator

10. Any known intolerance or hypersensitivity to topical anesthetics, mydriatics,post-operative antibiotic or steroid drops , topical intraocular pressurelowering drops, allergy to sulfa drugs, or inability to tolerate oralintraocular pressure lowering drugs, or any component of the device

11. History of ocular or periocular malignancy in the study eye within the previousfive years

12. Current or prior history of herpes simplex virus (HSV) or Varicella-zostervirus (VZV) keratitis in the study eye.

13. History of shingles vaccination in the past year or intent to receive thevaccine during the study period

14. Current or prior history of uveitis in the study eye

15. Current or prior history of scleritis or retinitis in the study eye

16. Uncontrolled glaucoma defined by having one or both of the below:

• Intraocular pressure of greater than 21 mm Hg
• Intraocular pressure above the specific target pressure for the patientNOTE: Patients with history of glaucoma who are on topical glaucomamedications or who have undergone glaucoma surgery with intraocularpressure within the target range are eligible

17. Hypotony in the study eye, as evidenced by an intraocular pressure of < 6 mmHg

18. Presence of broad anterior synechia greater than a quadrant, defined by havingboth of the below:

• 3 contiguous clock hours of synechia
• Involving the central 8 mm of the cornea

19. Presence of significant corneal stromal vascularization, defined by having bothof the below:

• 3 contiguous clock hours of vascularization
• Involving the central 8 mm of the cornea

20. Retinal detachment within 30 days prior to surgery. NOTE: Patients with a priorhistory of retinal detachment surgery are eligible, unless they currently havesilicone oil in the posterior segment

21. Current (or prior) history of other keratoprosthesis device implantation

22. Monocular status

23. Inability to wear a soft contact lens due to conjunctival or lid abnormalities

24. Signs of current (within the two weeks prior to surgery) systemic infection,including fever and current treatment with antibiotics

25. Participation in another simultaneous interventional medical investigation ortrial that may have a reasonable likelihood of affecting the outcomes of thepresent study

26. Have any other history of clinically severe diseases, or conditions that in theopinion of the investigator, may affect the results of the study

27. Any current or history of substance abuse, psychiatric disorder or a conditionthat, in the opinion of the investigator, may invalidate communication oradherence to study procedures

28. Patients who are unable to comply with the study procedures and follow-upvisits throughout the study period (12 months)