Trial Outcomes & Findings for Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis (NCT NCT01582880)
NCT ID: NCT01582880
Last Updated: 2019-10-21
Results Overview
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.
COMPLETED
PHASE1/PHASE2
1 participants
measured at week 4, 6, 26, 32, 52
2019-10-21
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis
Baseline characteristics by cohort
| Measure |
Riboflavin Cross-linked Donor Cornea
n=1 Participants
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
|
|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION NA • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
|
corneal thickness measured at 1mm one day post op
|
730 µm
n=5 Participants
|
|
corneal thickness measured at 2mm one day post op
|
940 µm
n=5 Participants
|
PRIMARY outcome
Timeframe: measured at week 4, 6, 26, 32, 52Population: 52 year old white male patient
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.
Outcome measures
| Measure |
Riboflavin Cross-linked Donor Cornea
n=1 Participants
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
|
|---|---|
|
Changes in Corneal Thickness at 1 Millimeter
week 4 corneal thickness
|
730 micrometer
|
|
Changes in Corneal Thickness at 1 Millimeter
week 6 corneal thickness
|
760 micrometer
|
|
Changes in Corneal Thickness at 1 Millimeter
week 26 corneal thickness
|
700 micrometer
|
|
Changes in Corneal Thickness at 1 Millimeter
week 32 corneal thickness
|
720 micrometer
|
|
Changes in Corneal Thickness at 1 Millimeter
week 52 corneal thickness
|
680 micrometer
|
PRIMARY outcome
Timeframe: measured at week 4, 6, 26, 32, 52Population: 52 year old white male patient
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.
Outcome measures
| Measure |
Riboflavin Cross-linked Donor Cornea
n=1 Participants
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
|
|---|---|
|
Changes in Corneal Thickness at 2 Millimeter
week 6 corneal thickness
|
860 micrometer
|
|
Changes in Corneal Thickness at 2 Millimeter
week 26 corneal thickness
|
820 micrometer
|
|
Changes in Corneal Thickness at 2 Millimeter
week 32 corneal thickness
|
795 micrometer
|
|
Changes in Corneal Thickness at 2 Millimeter
week 52 corneal thickness
|
780 micrometer
|
|
Changes in Corneal Thickness at 2 Millimeter
week 4 corneal thickness
|
940 micrometer
|
SECONDARY outcome
Timeframe: post op week 52Population: 52 year old white male
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.
Outcome measures
| Measure |
Riboflavin Cross-linked Donor Cornea
n=1 Participants
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
|
|---|---|
|
Number of Occurrences of Vitritis (Sterile or Infectious) Ulcers
|
0 occurrences
|
SECONDARY outcome
Timeframe: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52Population: 52 year old white male
Incidence and severity of ocular adverse events during the study (ophthalmic examination, adverse events spontaneously reported)
Outcome measures
| Measure |
Riboflavin Cross-linked Donor Cornea
n=1 Participants
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
|
|---|---|
|
Ocular Safety
|
0 Incidences
|
SECONDARY outcome
Timeframe: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52Population: 52 year old white male
Incidence and severity of systemic adverse events during the study (clinical laboratory, adverse events spontaneously reported).
Outcome measures
| Measure |
Riboflavin Cross-linked Donor Cornea
n=1 Participants
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
|
|---|---|
|
Systemic Safety
|
0 Incidences
|
Adverse Events
Riboflavin Cross-linked Donor Cornea
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Joseph Ciolino, MD
Massachusetts Eye and Ear Infirmary
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place