Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis
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ClinicalTrials.gov Identifier: NCT01582880 |
Recruitment Status
:
Completed
First Posted
: April 23, 2012
Results First Posted
: July 24, 2017
Last Update Posted
: September 18, 2017
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Condition or disease | Intervention/treatment | Phase |
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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 | Drug: Riboflavin | Phase 1 Phase 2 |
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 |

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.
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Drug: Riboflavin
Used to treat donor cornea before implantation
Other Name: Riboflavin (vitamin B2) 0.1% solution
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- 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.
- 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.
- 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.
- 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)
- 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).

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01582880
United States, Massachusetts | |
Massachusetts Eye and Ear Infirmary | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Joseph Ciolino, MD | Massachusetts Eye and Ear Infirmary |
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 Key Record Dates |
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 |