Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase I/II Prospective, Randomized, Multicenter, Double-Masked, Vehicle-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Corneal Collagen Cross-Linking of Keratoprosthesis Carrier Tissue in High-Risk Keratoprosthesis Implantation
Brief Summary: This is a phase I/II prospective, randomized, multi-center, double-masked, vehicle-controlled clinical trial evaluating the safety and efficacy of corneal collagen cross-linking the keratoprosthesis carrier tissue in subjects who are candidates for high-risk keratoprosthesis implantation but because of a history of corneal melts or autoimmune diseases are not candidate for a traditional corneal transplant.


Options:
A: Inclusion Criteria:

* Subjects with infectious keratitis (initial or refractory to treatment) including bacterial or mycotic keratitis with size larger than 3 mm

Exclusion Criteria:

* herpetic keratitis
* Acanthamoeba keratitis
* pregnancy
* endophthalmitis
* systemic immunosuppression
B: Inclusion criteria:

* Corneal ulcer that is smear positive for either bacteria or filamentous fungus
* Pinhole visual acuity worse than 20/70 in the affected eye
* Not treated already with antimicrobial medications at presentation
* Age over 18 years
* Basic understanding of the study as determined by the physician
* Commitment to return for follow up visits

Exclusion criteria:

* Evidence of concomitant infection on exam or gram stain (i.e. herpes, both bacteria and acanthamoeba on gram stain)
* Impending or frank perforation at recruitment
* Involvement of sclera at presentation
* Non-infectious or autoimmune keratitis
* History of corneal transplantation or recent intraocular surgery
* No light perception in the affected eye
* Pinhole visual acuity worse than 20/200 in the unaffected eye
* Participants who are decisionally and/or cognitively impaired
C: Inclusion Criteria:

* diagnosis of infectious keratitis

Exclusion Criteria:

* corneal ulcer that has perforated
* corneal ulcer that has produced a descemetocele
* women who are pregnant or breastfeeding
* patients who are immunocompromised or unwilling or unable to comply with a medication regimen
D: Inclusion Criteria:

* Willing and able to provide written informed consent
* Willing and able to comply with study assessments for the full duration of the study
* Age ≥ 18 years
* Candidate for a Boston Keratoprosthesis / Cornea transplant
* In generally good stable overall health
* Patients with an eye at risk for a cornea sterile ulcer which includes:

  * Autoimmune diseases (mucus membrane pemphigoid, Stevens-Johnson syndrome, systemic lupus erythematosis, rheumatoid arthritis, or other autoimmune diseases); OR
  * History of previous sterile cornea ulceration requiring a cornea transplant

Exclusion Criteria:

* Age \< 18 years
* Inability to provide written informed consent and comply with study assessments for the full duration of the study
* No or minimal tear production with evidence of keratinization of the bulbar conjunctiva
* Corneal or ocular surface infection within 30 days prior to study entry
* Ocular or periocular malignancy
* Inability to wear a contact lens due to lid abnormalities or shortened fornix
* Signs of current infection, including fever and current treatment with antibiotics
* Pregnancy (positive pregnancy test) or lactating
* Participation in another simultaneous interventional medical investigation or trial

Answer: D