Autoimmune Diseases, Chemical Injuries, Lupus Erythematosus, Systemic, Ocular Cicatricial Pemphigoid, Other Autoimmune Diseases, Rheumatoid Arthritis, Stevens Johnson Syndrome, Unspecified Complication of Corneal Transplant
Conditions
Keywords
Keratoprosthesis, sterile cornea ulcer
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).
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.
Interventions
DRUGRiboflavin
Used to treat donor cornea before implantation
Sponsors
Joseph B. Ciolino, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Corneal Thickness at 1 Millimeter | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Occurrences of Vitritis (Sterile or Infectious) Ulcers | 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 | 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 | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Riboflavin Cross-linked Donor Cornea |
|---|---|
| Age, Continuous | 52 years |
| corneal thickness measured at 1mm one day post op | 730 µm |
| corneal thickness measured at 2mm one day post op | 940 µm |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
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.
Time frame: measured at week 4, 6, 26, 32, 52
Population: 52 year old white male patient
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Riboflavin Cross-linked Donor Cornea | Changes in Corneal Thickness at 1 Millimeter | week 4 corneal thickness | 730 micrometer |
| Riboflavin Cross-linked Donor Cornea | Changes in Corneal Thickness at 1 Millimeter | week 6 corneal thickness | 760 micrometer |
| Riboflavin Cross-linked Donor Cornea | Changes in Corneal Thickness at 1 Millimeter | week 26 corneal thickness | 700 micrometer |
| Riboflavin Cross-linked Donor Cornea | Changes in Corneal Thickness at 1 Millimeter | week 32 corneal thickness | 720 micrometer |
| Riboflavin Cross-linked Donor Cornea | Changes in Corneal Thickness at 1 Millimeter | week 52 corneal thickness | 680 micrometer |
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.
Time frame: measured at week 4, 6, 26, 32, 52
Population: 52 year old white male patient
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Riboflavin Cross-linked Donor Cornea | Changes in Corneal Thickness at 2 Millimeter | week 4 corneal thickness | 940 micrometer |
| Riboflavin Cross-linked Donor Cornea | Changes in Corneal Thickness at 2 Millimeter | week 6 corneal thickness | 860 micrometer |
| Riboflavin Cross-linked Donor Cornea | Changes in Corneal Thickness at 2 Millimeter | week 26 corneal thickness | 820 micrometer |
| Riboflavin Cross-linked Donor Cornea | Changes in Corneal Thickness at 2 Millimeter | week 32 corneal thickness | 795 micrometer |
| Riboflavin Cross-linked Donor Cornea | Changes in Corneal Thickness at 2 Millimeter | week 52 corneal thickness | 780 micrometer |
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.
Time frame: post op week 52
Population: 52 year old white male
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Riboflavin Cross-linked Donor Cornea | Number of Occurrences of Vitritis (Sterile or Infectious) Ulcers | 0 occurrences |
Secondary
Ocular Safety
Incidence and severity of ocular adverse events during the study (ophthalmic examination, adverse events spontaneously reported)
Time frame: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52
Population: 52 year old white male
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Riboflavin Cross-linked Donor Cornea | Ocular Safety | 0 Incidences |
Secondary
Systemic Safety
Incidence and severity of systemic adverse events during the study (clinical laboratory, adverse events spontaneously reported).
Time frame: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52
Population: 52 year old white male
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Riboflavin Cross-linked Donor Cornea | Systemic Safety | 0 Incidences |