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

Study Description

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Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Chemical Injuries; Unspecified Complication of Corneal Transplant; Autoimmune Diseases; Ocular Cicatricial Pemphigoid; Stevens Johnson Syndrome; Lupus Erythematosus, Systemic; Rheumatoid Arthritis; Other Autoimmune Diseases	Drug: Riboflavin	Phase 1; Phase 2

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	The Use of Riboflavin/Ultraviolet A Cross-linked Human Donor Corneas as Carriers for the Boston Keratoprosthesis
Study Start Date :	March 2012
Actual Primary Completion Date :	March 2014
Actual Study Completion Date :	March 2014

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Riboflavin Cross-linked donor cornea; 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; Used to treat donor cornea before implantation; Other Name: Riboflavin (vitamin B2) 0.1% solution

Outcome Measures

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Primary Outcome Measures :

1. Changes in Corneal Thickness at 1 Millimeter [ Time Frame: measured at week 4, 6, 26, 32, 52 ]
   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.
2. Changes in Corneal Thickness at 2 Millimeter [ Time Frame: measured at week 4, 6, 26, 32, 52 ]
   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.

Secondary Outcome Measures :

1. Number of Occurrences of Vitritis (Sterile or Infectious) Ulcers [ Time Frame: post op week 52 ]
   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.
2. Ocular Safety [ Time Frame: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52 ]
   Incidence and severity of ocular adverse events during the study (ophthalmic examination, adverse events spontaneously reported)
3. Systemic Safety [ Time Frame: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52 ]
   Incidence and severity of systemic adverse events during the study (clinical laboratory, adverse events spontaneously reported).

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Ability to provide written informed consent and comply with study assessments for the full duration of the study.
2. Age > 18 years.
3. A negative urine pregnancy test.
4. Candidate for a Boston Keratoprosthesis/Corneal transplant.
5. Generally good stable overall health.

6. 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:

1. Age < 18 years.
2. Inability to provide written informed consent and comply with study assessments for the full duration of the study.
3. Pregnant or lactating women.
4. No or minimal tear production.
5. Ocular or periocular malignancy.
6. Inability to wear a contact lens due to lid abnormalities or shortened fornix.
7. Signs of current infection, including fever and current treatment with antibiotics.
8. Participation in another simultaneous medical investigation or trial

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Massachusetts
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Joseph B. Ciolino, MD

Investigators

Principal Investigator:	Joseph Ciolino, MD	Massachusetts Eye and Ear Infirmary

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Joseph B. Ciolino, MD, Principal Investigator, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:	NCT01582880 History of Changes
Other Study ID Numbers:	10-03-020
First Posted:	April 23, 2012
Results First Posted:	July 24, 2017
Last Update Posted:	September 18, 2017
Last Verified:	September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Joseph B. Ciolino, MD, Massachusetts Eye and Ear Infirmary:

Keratoprosthesis; sterile cornea ulcer

Additional relevant MeSH terms:

Arthritis, Rheumatoid; Autoimmune Diseases; Lupus Erythematosus, Systemic; Pemphigoid, Bullous; Stevens-Johnson Syndrome; Pemphigoid, Benign Mucous Membrane; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Immune System Diseases; Skin Diseases, Vesiculobullous; Skin Diseases; Stomatitis	Mouth Diseases; Stomatognathic Diseases; Drug Eruptions; Dermatitis; Erythema Multiforme; Erythema; Drug Hypersensitivity; Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Conjunctival Diseases; Eye Diseases; Riboflavin; Vitamin B Complex; Vitamins