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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Riboflavin Cross-linked donor cornea | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riboflavin | Drug | Used to treat donor cornea before implantation |
|
| 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 |
| 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 |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Ciolino, MD | Massachusetts Eye and Ear Infirmary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts Eye and Ear Infirmary | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Riboflavin: Used to treat donor cornea before implantation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Riboflavin: Used to treat donor cornea before implantation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| corneal thickness measured at 1mm one day post op | "corneal thickness measured at 1mm one day post op" is the baseline measurement for this study. This study evaluated cross-linked cornea tissue versus standard of care cornea tissue after transplant procedure. Therefore the measurement at one day post op is the baseline measurement. | Number | µm |
| |||||||||||||||||
| corneal thickness measured at 2mm one day post op | "corneal thickness measured at 2mm one day post op" is the baseline measurement for this study. This study evaluated cross-linked cornea tissue versus standard of care cornea tissue after transplant procedure. Therefore the measurement at one day post op is the baseline measurement. | Number | µm |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 52 year old white male patient | Posted | Number | micrometer | measured at week 4, 6, 26, 32, 52 |
|
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| Primary | 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. | 52 year old white male patient | Posted | Number | micrometer | measured at week 4, 6, 26, 32, 52 |
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| Secondary | 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. | 52 year old white male | Posted | Number | occurrences | post op week 52 |
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| Secondary | Ocular Safety | Incidence and severity of ocular adverse events during the study (ophthalmic examination, adverse events spontaneously reported) | 52 year old white male | Posted | Number | Incidences | measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52 |
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| Secondary | Systemic Safety | Incidence and severity of systemic adverse events during the study (clinical laboratory, adverse events spontaneously reported). | 52 year old white male | Posted | Number | Incidences | measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52 |
|
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This study enrolled one study subject. The study subject was followed for Adverse Events from the time of signing the study informed consent form 2/12/2013 to one year post surgery 3/13/2014
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Riboflavin Cross-linked Donor Cornea | The donor cornea used as a carrier for the Boston Keratoprosthesis underwent crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis. Riboflavin: Used to treat donor cornea before implantation | 0 | 1 | 0 | 1 | 0 | 1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joseph Ciolino, MD | Massachusetts Eye and Ear Infirmary | 617-573-4437 | joseph_ciolino@meei.harvard.edu |
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D010390 | Pemphigoid, Benign Mucous Membrane |
| D013262 | Stevens-Johnson Syndrome |
| D008180 | Lupus Erythematosus, Systemic |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D012872 | Skin Diseases, Vesiculobullous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003875 | Drug Eruptions |
| D003872 | Dermatitis |
| D004892 | Erythema Multiforme |
| D004890 | Erythema |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D004342 | Drug Hypersensitivity |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D003240 | Connective Tissue Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D012256 | Riboflavin |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D005415 | Flavins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D004364 | Pharmaceutical Preparations |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| week 32 corneal thickness |
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| week 52 corneal thickness |
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