Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis

Study Overview
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Brief Summary
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The purpose of the pilot study is to test the efficacy and safety of riboflavin/Ultraviolet A (UVA) cross-linked human donor corneas as carriers for the Boston Keratoprosthesis (Boston KPro) in patients with higher risk for corneal melting (keratolysis).

Detailed Description
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The corneal cross-linking technique has been shown to strengthen the cornea and resist degradation by the body's own enzymes. The use of highly-resistant donor corneas is meant to eliminate the serious post-operative complication of corneal melting (keratolysis) that repeatedly occurs in Boston KPro patients with severe ocular burns, autoimmune and cicatrizing diseases.

Official Title
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The Use of Riboflavin/Ultraviolet A Cross-linked Human Donor Corneas as Carriers for the Boston Keratoprosthesis

Conditions
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Chemical Injuries, Unspecified Complication of Corneal Transplant, Autoimmune Diseases, Ocular Cicatricial Pemphigoid, Stevens Johnson Syndrome, Lupus Erythematosus, Systemic, Rheumatoid Arthritis, Other Autoimmune Diseases

Intervention / Treatment
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* Drug: Riboflavin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to provide written informed consent and comply with study assessments for the full duration of the study. Age > 18 years. A negative urine pregnancy test. Candidate for a Boston Keratoprosthesis/Corneal transplant. Generally good stable overall health. Patients with an eye at risk for a cornea sterile ulcer which includes: Chemical injuries. Autoimmune diseases (ocular cicatricial pemphigoid, Stevens Johnson Syndrome, systemic lupus erythematosus, rheumatoid arthritis, or other autoimmune diseases). History of previous sterile corneal 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. Pregnant or lactating women. No or minimal tear production. 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. Participation in another simultaneous medical investigation or trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Riboflavin Cross-linked donor cornea<br>the donor cornea used as a carrier for the Boston Keratoprosthesis will undergo crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis. | Drug: Riboflavin<br>* Used to treat donor cornea before implantation<br>* Other names: Riboflavin (vitamin B2) 0.1% solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Corneal Thickness at 1 Millimeter | The average carrier graft thickness over the first year of postoperative follow-up. The corneal thickness was measured at each visit using AS-OCT imaging 1 mm away from the KPro stem at 3, 6, 9, and 12 o'clock. The individual corneal thickness measurements (3, 6, 9, and 12 o'clock) where then averaged. The average corneal thickness measurements for week 4, 6, 26, 32 and 52 are reported below. | measured at week 4, 6, 26, 32, 52 | 
| Changes in Corneal Thickness at 2 Millimeter | The average carrier graft thickness over the first year of postoperative follow-up. The corneal thickness was measured at each visit using AS-OCT imaging 2 mm away from the KPro stem at 3, 6, 9, and 12 o'clock. The individual corneal thickness measurements (3, 6, 9, and 12 o'clock) where then averaged. The average corneal thickness measurements for week 4, 6, 26, 32 and 52 are reported below. | measured at week 4, 6, 26, 32, 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Occurrences of Vitritis (Sterile or Infectious) Ulcers | Number of occurrence of vitritis (sterile or infectious) ulcers. Incidences of ulcers were collected by way of slit lamp photography from time of surgery to final visit. | post op week 52 | 
| Ocular Safety | Incidence and severity of ocular adverse events during the study (ophthalmic examination, adverse events spontaneously reported) | measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52 | 
| Systemic Safety | Incidence and severity of systemic adverse events during the study (clinical laboratory, adverse events spontaneously reported). | measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Keratoprosthesis, sterile cornea ulcer