Trial Outcomes & Findings for Cornea Donor Study (NCT NCT00006411)

Results Overview

\# eyes with graft failure, defined as a regraft or a cloudy cornea that was sufficiently opaque as to compromise vision for a minimum of three consecutive months. Only one eye per participant was included in the study.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1090 participants

Primary outcome timeframe

Baseline to 10 Years of Follow Up

Results posted on

2020-02-25

Participant Flow

Participant milestones

Participant milestones
Measure	Cornea Assigned From Donor Age Group <66.0 Years cornea assigned from donor age group \<66.0 years corneas assigned by donor age group: A web-based computer program was used to select and assign a cornea by donor age group from those available at the eye bank that met the study eligibility criteria. The program randomly selected a cornea based on a two-level minimization procedure which attempted first to balance for each surgeon the number of corneas from donors \>=66 and \<66 years old and then, when possible, to balance among age subgroups of 10-35, 36-50, 51-65, 66-70, and 71-75 years. The assignment was made without regard to recipient age or any other subject characteristics.	Cornea Assigned From Donor Age Group >= 66.0 Years cornea assigned from donor age group \>= 66.0 years corneas assigned by donor age group: A web-based computer program was used to select and assign a cornea by donor age group from those available at the eye bank that met the study eligibility criteria. The program randomly selected a cornea based on a two-level minimization procedure which attempted first to balance for each surgeon the number of corneas from donors \>=66 and \<66 years old and then, when possible, to balance among age subgroups of 10-35, 36-50, 51-65, 66-70, and 71-75 years. The assignment was made without regard to recipient age or any other subject characteristics.
Overall Study STARTED	707	383
Overall Study COMPLETED	707	383
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cornea Donor Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cornea Assigned From Donor Age Group <66.0 Years n=707 Participants cornea assigned from donor age group \<66.0 years corneas assigned by donor age group: A web-based computer program was used to select and assign a cornea by donor age group from those available at the eye bank that met the study eligibility criteria. The program randomly selected a cornea based on a two-level minimization procedure which attempted first to balance for each surgeon the number of corneas from donors \>=66 and \<66 years old and then, when possible, to balance among age subgroups of 10-35, 36-50, 51-65, 66-70, and 71-75 years. The assignment was made without regard to recipient age or any other subject characteristics.	Cornea Assigned From Donor Age Group >= 66.0 Years n=383 Participants cornea assigned from donor age group \>= 66.0 years corneas assigned by donor age group: A web-based computer program was used to select and assign a cornea by donor age group from those available at the eye bank that met the study eligibility criteria. The program randomly selected a cornea based on a two-level minimization procedure which attempted first to balance for each surgeon the number of corneas from donors \>=66 and \<66 years old and then, when possible, to balance among age subgroups of 10-35, 36-50, 51-65, 66-70, and 71-75 years. The assignment was made without regard to recipient age or any other subject characteristics.	Total n=1090 Participants Total of all reporting groups
Age, Continuous	69 years STANDARD_DEVIATION 9 • n=5 Participants	71 years STANDARD_DEVIATION 8 • n=7 Participants	70 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	445 Participants n=5 Participants	252 Participants n=7 Participants	697 Participants n=5 Participants
Sex: Female, Male Male	262 Participants n=5 Participants	131 Participants n=7 Participants	393 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 10 Years of Follow Up

\# eyes with graft failure, defined as a regraft or a cloudy cornea that was sufficiently opaque as to compromise vision for a minimum of three consecutive months. Only one eye per participant was included in the study.

Outcome measures

Outcome measures
Measure	Cornea Assigned From Donor Age Group <66.0 Years n=707 eyes cornea assigned from donor age group \<66.0 years corneas assigned by donor age group: A web-based computer program was used to select and assign a cornea by donor age group from those available at the eye bank that met the study eligibility criteria. The program randomly selected a cornea based on a two-level minimization procedure which attempted first to balance for each surgeon the number of corneas from donors \>=66 and \<66 years old and then, when possible, to balance among age subgroups of 10-35, 36-50, 51-65, 66-70, and 71-75 years. The assignment was made without regard to recipient age or any other subject characteristics.	Cornea Assigned From Donor Age Group >= 66.0 Years n=383 eyes cornea assigned from donor age group \>= 66.0 years corneas assigned by donor age group: A web-based computer program was used to select and assign a cornea by donor age group from those available at the eye bank that met the study eligibility criteria. The program randomly selected a cornea based on a two-level minimization procedure which attempted first to balance for each surgeon the number of corneas from donors \>=66 and \<66 years old and then, when possible, to balance among age subgroups of 10-35, 36-50, 51-65, 66-70, and 71-75 years. The assignment was made without regard to recipient age or any other subject characteristics.
Graft Failure	142 participants	82 participants

SECONDARY outcome

Timeframe: 10 year ECD

Population: Of 1,090 eligible participants enrolled in the CDS, the SMAS included 609. A gradable endothelial image at 10 years was available for 176 participants. Among the other 433 participants, 105 had a graft failure, 100 died, 103 completed less than 10 years of CDS follow up, and 125 did not have a 10-year image for other reasons.

ECD (cells/mm2)was measured on a subset of the overall Cornea Donor Study cohort who participated in the Specular Microscopy Ancillary Study

Outcome measures

Outcome measures
Measure	Cornea Assigned From Donor Age Group <66.0 Years n=125 Participants cornea assigned from donor age group \<66.0 years corneas assigned by donor age group: A web-based computer program was used to select and assign a cornea by donor age group from those available at the eye bank that met the study eligibility criteria. The program randomly selected a cornea based on a two-level minimization procedure which attempted first to balance for each surgeon the number of corneas from donors \>=66 and \<66 years old and then, when possible, to balance among age subgroups of 10-35, 36-50, 51-65, 66-70, and 71-75 years. The assignment was made without regard to recipient age or any other subject characteristics.	Cornea Assigned From Donor Age Group >= 66.0 Years n=51 Participants cornea assigned from donor age group \>= 66.0 years corneas assigned by donor age group: A web-based computer program was used to select and assign a cornea by donor age group from those available at the eye bank that met the study eligibility criteria. The program randomly selected a cornea based on a two-level minimization procedure which attempted first to balance for each surgeon the number of corneas from donors \>=66 and \<66 years old and then, when possible, to balance among age subgroups of 10-35, 36-50, 51-65, 66-70, and 71-75 years. The assignment was made without regard to recipient age or any other subject characteristics.
Endothelial Cell Density (ECD)	628 ECD (cells/mm2) Interval 522.0 to 850.0	550 ECD (cells/mm2) Interval 483.0 to 694.0

Adverse Events

Cornea Assigned From Donor Age Group <66.0 Years

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cornea Assigned From Donor Age Group >= 66.0 Years

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Roy W. Beck, MD, PhD

JCHR

Phone: 813-975-8690

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place