| Eligibility |
Key Inclusion Criteria:
- Patients must meet all of the following criteria to be eligible to be consented for
this study.
1. 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.
2. Male or female patients = 18 years old at the time of consent
3. 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.)
4. 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
5. Best corrected distance visual acuity of worse than 20/400 in the study eye using
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 chamber intraocular
lens (IOL) implant centered within the capsular bag or sulcus
8. 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)
9. If applicable, prior corneal transplant = 8 mm in diameter
10. Adequate lid function and normal ocular surface and tear film parameters for
implant of the study device, as determined by the investigator.
Key Exclusion Criteria:
- Patients who meet any of the following exclusion criteria cannot be consented and
included in this study:
1. Inability to provide written informed consent and comply with study assessments
for the full duration of the study.
2. Age: < 18 years
3. Patients who are pregnant/nursing or planning to become pregnant during the
study.
Note: For women of child-bearing potential, confirmation of pregnancy status must
be documented per site standard.
4. Corneal thickness measurement (epithelium to endothelium; central and
mid-peripheral/ 3 to 5mm away from center at superior, inferior, nasal and
temporal quadrants) in the study eye with any measurement less than 700um or more
than 900um measured using US pachymetry. If one or more measurements cannot be
obtained using US pachymetry, measurements using anterior segment OCT may 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 unstable
posterior 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 plugs or
cauterization) if the Schirmer's are adequate following the procedure
- Evidence of conjunctival or lid margin keratinization
- Presence of cicatrizing conjunctivitis (Stevens Johnson Syndrome, mucous
membrane 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 or
persistent corneal epithelial defects
- Prior history of immune-mediated/ non-infectious keratolysis with or without
underlying systemic disease
- Significant lid margin disease with infestation/infection within 30 days
prior 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 eye within
30 days prior to surgery.
NOTE: Patient can be eligible after successful treatment and resolution as
determined by the investigator
10. Any known intolerance or hypersensitivity to topical anesthetics, mydriatics,
post-operative antibiotic or steroid drops , topical intraocular pressure
lowering drops, allergy to sulfa drugs, or inability to tolerate oral intraocular
pressure lowering drugs, or any component of the device
11. History of ocular or periocular malignancy in the study eye within the previous
five years
12. Current or prior history of herpes simplex virus (HSV) or Varicella-zoster virus
(VZV) keratitis in the study eye.
13. History of shingles vaccination in the past year or intent to receive the vaccine
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 patient
NOTE: Patients with history of glaucoma who are on topical glaucoma
medications or who have undergone glaucoma surgery with intraocular pressure
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 having
both 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 both
of 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 prior
history of retinal detachment surgery are eligible, unless they currently have
silicone 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 or
trial that may have a reasonable likelihood of affecting the outcomes of the
present study
26. Have any other history of clinically severe diseases, or conditions that in the
opinion of the investigator, may affect the results of the study
27. Any current or history of substance abuse, psychiatric disorder or a condition
that, in the opinion of the investigator, may invalidate communication or
adherence to study procedures
28. Patients who are unable to comply with the study procedures and follow-up visits
throughout the study period (12 months)
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