Corneal DiseaseCDSNCT00006411
Cornea Donor Study
A study testing corneas assigned by donor age group in people with Corneal Disease and Fuch's Dystrophy, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
The Cornea Donor Study (CDS) was designed as a prospective cohort study with the following objectives: To determine whether the graft-failure rate over a 5-year follow-up period following corneal transplantation is the same when using corneal tissue from donors older than 65 years of age compared with tissue from… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Corneal Disease, Fuch's Dystrophy, Pseudophakic Corneal Edema
- What is being tested?
- corneas assigned by donor age group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,090 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2000to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range 40-80 years
- Corneal disease: Presence of a condition associated with endothelial dysfunction, including pseudophakic/aphakic corneal edema, Fuchs' dystrophy, posterior polymorphous dystrophy, interstitial keratitis (nonherpetic) or perforating corneal injury
- Willingness to be followed for 5 years and life expectancy at least 5 years (in investigator's judgement)
Who cannot join
- Patients are to be excluded when there is:
- a high risk of graft failure, including failed prior penetrating keratoplasty in the eye to be transplanted, chemical burns or other significant cicatricial conjunctivitis (ocular surface disease), herpes simplex/zoster, temporary keratoprosthesis, iridocorneal endothelial syndrome or any corneal condition in which there are two or more quadrants of stromal neovascularization
- A quadrant is considered vascularized if there is at least one patent stromal vessel >2.0 mm in length crossing the limbus within a quadrant. Two quadrants are considered vascularized if there are at least two stromal vessels 90º or more apart. Enrollment will be restricted to no more than 20% of the total cohort having stromal neovascularization.
- Patients should be excluded if there are PAS or other abnormalities that, in the view of the investigator, place the patient at high risk for graft failure.
- a very high probability of success including keratoconus, stromal dystrophies, stromal scars without edema or post-refractive surgery with healthy endothelium
- Uncontrolled glaucoma or prior filtering surgery with placement of a shunt in the eye to be grafted (Note: eyes requiring a filtering procedure combined with the PK are considered to have uncontrolled glaucoma and are ineligible. Eyes which have undergone filtering surgery (without a shunt) in which glaucoma is currently considered under control are eligible)
Show all 9Show fewer
- Uncontrolled uveitis in the eye to be grafted
- Fellow eye visual acuity <20/200
- Fellow eye already included in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Jaeb Center for Health Research, Inc.
Tampa, Florida, 33647
About this study
Official title: Cornea Donor Study: The Effect of Donor Age on Penetrating Keratoplasty for Endothelial Disease
The Cornea Donor Study (CDS) was designed as a prospective cohort study with the following objectives:
To determine whether the graft-failure rate over a 5-year follow-up period following corneal transplantation is the same when using corneal tissue from donors older than 65 years of age compared with tissue from younger donors.
To assess the relationship between donor/recipient ABO blood type compatibility and graft failure due to rejection.
To assess corneal endothelial cell density as an indicator of the health of the cornea and as a alternate outcome measure (in an optional Specular Microscopy Ancillary Study).
Read the detailed description
The study enrolled 1101 subjects with a corneal disease considered to be at moderate risk for failure (principally Fuchs' dystrophy and pseudophakic corneal edema). A donor cornea meeting the following criteria was assigned to the subject by one of 43 participating eye banks:
- donor age 10 to 75 years
- endothelial cell count 2300 to 3300
- tissue quality very good to excellent
- death to preservation time <12 hrs if body refrigerated or eyes on ice and <8 hrs if not
- death to surgery time <5 days
The cornea surgeon (investigator) and patient were masked to donor age and characteristics of the donor cornea. Preoperative management, surgical technique, and postoperative care, including prescription of medications, were provided according to each investigator's customary routine. The follow-up visit schedule for the initial six months was left to each investigator's discretion and after this time the minimum follow-up visit schedule included a visit between six and 12 months and then one visit every 12 months through five years. The primary study outcome was graft survival at five years. The definition of graft failure, based on the definition used in Collaborative Corneal Transplantation Studies, was a regraft or, in the absence of regraft, a cloudy cornea in which there was loss of central graft clarity sufficient to compromise vision for a minimum of three consecutive months. Follow-up in the initial phase of the study continued for five years unless the patient had a regraft of the study eye.
For the ABO compatibility study, the ABO blood type of both the donor and recipient were determined in order to compare the rate of graft failure for ABO-compatible cases with the rate for ABO-incompatible cases.
For the Specular Microscopy Ancillary Study, endothelial cell counts were determined from specular images by a central reading center, and the relationship of the cell counts to donor age were assessed. In the initial phase of the study, specular images were obtained at 6 months, and then annually through five years post-transplant.
Five-year follow up was completed in November 2007. The 5-year cumulative probability of success was 86%: 86% in the <66.0 year donor age group and 86% in the >=66.0 year donor age group (difference = 0%, upper limit of one-sided 95% confidence interval = 4%). Adjusting for baseline endothelial cell density had no appreciable effect on these results. In a statistical model with donor age as a continuous variable, there was not a significant relationship between donor age and outcome (P=0.11). Three graft failures were due to primary donor failure, 8 to uncorrectable refractive error, 48 to graft rejection, 46 to endothelial decompensation, and 30 to other causes. At least one probable or definite graft rejection episode preceded graft failure in 23 of the 46 failures attributed to endothelial decompensation (4 definite and 19 probable) and in 18 of the 30 failures attributed to other causes (4 definite and 14 probable). The distribution of causes of failure between the donor age groups did not substantially differ.
Although the 5-year results indicated no difference in the success rate of moderate-risk transplants according to donor age, results from the SMAS indicated that among the successful cases, there was a slight association between donor age and endothelial cell loss, with the cell loss after 5 years being slightly lower in corneas from younger donors (r adjusted for baseline endothelial cell density = -0.19, 95% confidence interval -0.29 to -0.08). Whether this slight association between cell loss and donor age is of clinical importance is not known. Of perhaps even greater importance, however, was the finding that irrespective of donor age, endothelial cell loss was substantial over the first five years after transplant even when the graft had been successful. Half of the successful cases experienced a cell loss of 70% or more, and at five years more than half had an endothelial cell density <800 cells/mm2.
Patients in the CDS continued in annual follow up through 2012 in order to to determine the overall 10-year survival rate for moderate risk grafts and to determine whether the graft-failure rate is related to donor age. Additional objectives included determining the value of endothelial cell density in predicting graft failure and evaluating donor and recipient characteristics that may be predictive of late graft failure. All CDS subjects who were active at the 5-year exam were eligible for the extended follow-up phase.
As part of the Specular Microscopy Ancillary Study, follow-up images were obtained during the extended follow-up phase at 7-8 years and again at 10-years. The same procedures used during the first 5 years were followed for the grading of the 7-8 year and 10-year images.
- Being tested
- corneas assigned by donor age group
- Keywords
- cornea transplant, corneal endothelial cell density, moderate risk corneal diseases, corneal transplantation
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corneas assigned by donor age groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | cornea assigned from donor age group <66.0 years Receives: Other: corneas assigned by donor age group |
| 2 | Active comparator | cornea assigned from donor age group >= 66.0 years Receives: Other: corneas assigned by donor age group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft Failure
# 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.
Measured: Baseline to 10 Years of Follow Up
Secondary outcomes (1)
Endothelial Cell Density (ECD)
ECD (cells/mm2)was measured on a subset of the overall Cornea Donor Study cohort who participated in the Specular Microscopy Ancillary Study
Measured: 10 year ECD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2000 (estimated)
- Study start10 Jan 2000
- Primary completion31 Dec 2012
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Corneal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,090 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eye Bank Association of America, Bausch & Lomb Incorporated, Tissue Banks International, Vision Share, Inc., San Diego Eye Bank, The Cornea Society, Katena Products, Inc., ViroMed Laboratories, Inc., Midwest Eye Banks, Konan Medical, Inc., Eye Bank for Sight Restoration, SightLife, Sight Society of Northeastern New York (Lions Eye Bank of Albany), Lions Eye Bank of Oregon
- Responsible party
- Sponsor
- Investigators
- Edward J Holland, MD, Study chair, University of Cincinnati and Cincinnati Eye InstituteMark J Mannis, MD, Study chair, University of California, DavisRoy W Beck, MD, PhD, Principal investigator, Jaeb Center for Health ResearchJonathan H Lass, MD, Principal investigator, (PI of Specular Microscopy Ancillary Study), Case Western Reserve University and University Hospitals Case Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006411
- Sponsor's protocol ID
- NEI-80
- Other IDs
- 5U10EY012358, 3U10EY012358-11S1, 5U10EY012728
- Acronym
- CDS
- Status last verified
- Aug 2018
- First submitted
- 13 Oct 2000
- Last updated
- 25 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Public dataset access: http://cds.jaeb.org/Studies.aspx?RecID=185
Publications
Beck RW, Gal RL, Mannis MJ, Holland EJ, Cavanagh HD, Foulks GN, Heck EL, Lindquist T, Macsai MS, Smith RE, Stark WJ, Stulting RD, Sugar J. Is donor age an important determinant of graft survival? Cornea. 1999 Sep;18(5):503-10. doi: 10.1097/00003226-199909000-00001. No abstract available.
PubMed 10487423Powe A, Gal RL, Beck RW, Mannis MJ, Holland EJ on behalf of the Cornea Donor Study Investigator Group. The Cornea Donor Study. Vision Pan-America 2009; 8:134-137.
Sugar A, Gal RL, Beck rW, Ruedy KJ, Blanton CL, Feder RS, Hardten DR, Holland EJ, Lass JH, Mannis MJ, O'Keefe MB; Cornea Donor Study Group. Baseline donor characteristics in the Cornea Donor Study. Cornea. 2005 May;24(4):389-96. doi: 10.1097/01.ico.0000151503.26695.f0.
PubMed 15829793Lass JH, Gal RL, Ruedy KJ, Benetz BA, Beck RW, Baratz KH, Holland EJ, Kalajian A, Kollman C, Manning FJ, Mannis MJ, McCoy K, Montoya M, Stulting D, Xing D; Cornea Donor Study Group. An evaluation of image quality and accuracy of eye bank measurement of donor cornea endothelial cell density in the Specular Microscopy Ancillary Study. Ophthalmology. 2005 Mar;112(3):431-40. doi: 10.1016/j.ophtha.2004.10.045.
PubMed 15745770Mannis MJ, Holland EJ, Beck RW, Belin MW, Goldberg MA, Gal RL, Kalajian AD, Kenyon KR, Kollman C, Ruedy KJ, Smith P, Sugar J, Stark WJ; Cornea Donor Study Group. Clinical profile and early surgical complications in the Cornea Donor Study. Cornea. 2006 Feb;25(2):164-70. doi: 10.1097/01.ico.0000164832.69668.4b.
PubMed 16371775Benetz BA, Gal RL, Ruedy KJ, Rice C, Beck RW, Kalajian AD, Lass JH; Cornea Donor Study Group. Specular microscopy ancillary study methods for donor endothelial cell density determination of Cornea Donor Study images. Curr Eye Res. 2006 Apr;31(4):319-27. doi: 10.1080/02713680500536738.
PubMed 16603465Cornea Donor Study Investigator Group; gal RL, Dontchev M, Beck RW, Mannis MJ, Holland EJ, Kollman C, Dunn SP, Heck EL, Lass JH, Montoya MM, Schultze RL, Stulting RD, Sugar A, Sugar J, Tennant B, Verdier DD. The effect of donor age on corneal transplantation outcome results of the cornea donor study. Ophthalmology. 2008 Apr;115(4):620-626.e6. doi: 10.1016/j.ophtha.2008.01.003.
PubMed 18387407Cornea Donor Study Investigator Group; Lass JH, Gal RL, Dontchev M, Beck RW, Kollman C, Dunn SP, Heck E, Holland EJ, Mannis MJ, Montoya MM, Schultze RL, Stulting RD, Sugar A, Sugar J, Tennant B, Verdier DD. Donor age and corneal endothelial cell loss 5 years after successful corneal transplantation. Specular microscopy ancillary study results. Ophthalmology. 2008 Apr;115(4):627-632.e8. doi: 10.1016/j.ophtha.2008.01.004.
PubMed 18387408Sugar A, Tanner JP, Dontchev M, Tennant B, Schultze RL, Dunn SP, Lindquist TD, Gal RL, Beck RW, Kollman C, Mannis MJ, Holland EJ; Cornea Donor Study Investigator Group. Recipient risk factors for graft failure in the cornea donor study. Ophthalmology. 2009 Jun;116(6):1023-8. doi: 10.1016/j.ophtha.2008.12.050. Epub 2009 Apr 23.
PubMed 19395036Sugar J, Montoya M, Dontchev M, Tanner JP, Beck R, Gal R, Gallagher S, Gaster R, Heck E, Holland EJ, Kollman C, Malling J, Mannis MJ, Woody J; Group Cornea Donor Study Investigator Group. Donor risk factors for graft failure in the cornea donor study. Cornea. 2009 Oct;28(9):981-5. doi: 10.1097/ICO.0b013e3181a0a3e6.
PubMed 19724216Dunn SP, Stark WJ, Stulting RD, Lass JH, Sugar A, Pavilack MA, Smith PW, Tanner JP, Dontchev M, Gal RL, Beck RW, Kollman C, Mannis MJ, Holland EJ; Cornea Donor Study Investigator Group. The effect of ABO blood incompatibility on corneal transplant failure in conditions with low-risk of graft rejection. Am J Ophthalmol. 2009 Mar;147(3):432-438.e3. doi: 10.1016/j.ajo.2008.09.021. Epub 2008 Dec 4.
PubMed 19056078Lass JH, Sugar A, Benetz BA, Beck RW, Dontchev M, Gal RL, Kollman C, Gross R, Heck E, Holland EJ, Mannis MJ, Raber I, Stark W, Stulting RD; Cornea Donor Study Investigator Group. Endothelial cell density to predict endothelial graft failure after penetrating keratoplasty. Arch Ophthalmol. 2010 Jan;128(1):63-9. doi: 10.1001/archophthalmol.2010.128.63.
PubMed 20065219Lass JH, Beck RW, Benetz BA, Dontchev M, Gal RL, Holland EJ, Kollman C, Mannis MJ, Price F Jr, Raber I, Stark W, Stulting RD, Sugar A; Cornea Donor Study Investigator Group. Baseline factors related to endothelial cell loss following penetrating keratoplasty. Arch Ophthalmol. 2011 Sep;129(9):1149-54. doi: 10.1001/archophthalmol.2011.102. Epub 2011 May 9.
PubMed 21555600Stulting RD, Sugar A, Beck R, Belin M, Dontchev M, Feder RS, Gal RL, Holland EJ, Kollman C, Mannis MJ, Price F Jr, Stark W, Verdier DD; Cornea Donor Study Investigator Group. Effect of donor and recipient factors on corneal graft rejection. Cornea. 2012 Oct;31(10):1141-7. doi: 10.1097/ICO.0b013e31823f77f5.
PubMed 22488114Sugar A, Montoya MM, Beck R, Cowden JW, Dontchev M, Gal RL, Kollman C, Malling J, Mannis MJ, Tennant B; Cornea Donor Study Investigator Group. Impact of the cornea donor study on acceptance of corneas from older donors. Cornea. 2012 Dec;31(12):1441-5. doi: 10.1097/ICO.0b013e31823f7550.
PubMed 22262218
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cornea Donor Study: The Effect of Donor Age on Penetrating Keratoplasty for Endothelial Disease
- ClinicalTrials.gov ID
- NCT00006411
- Acronym / sponsor ID
- CDS / NEI-80
- Keywords
- cornea transplant, corneal endothelial cell density, moderate risk corneal diseases, corneal transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,090 participants (actual)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Collaborators
- Eye Bank Association of America, Bausch & Lomb Incorporated, Tissue Banks International, Vision Share, Inc., San Diego Eye Bank, The Cornea Society, Katena Products, Inc., ViroMed Laboratories, Inc., Midwest Eye Banks, Konan Medical, Inc., Eye Bank for Sight Restoration, SightLife, Sight Society of Northeastern New York (Lions Eye Bank of Albany), Lions Eye Bank of Oregon
- Study start
- 10 Jan 2000 (actual)
- Primary completion
- 31 Dec 2012 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 16 Oct 2000 (estimated)
- Results
- Posted 25 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Cornea Donor Study (CDS) was designed as a prospective cohort study with the following objectives:
To determine whether the graft-failure rate over a 5-year follow-up period following corneal transplantation is the same when using corneal tissue from donors older than 65 years of age compared with tissue from younger donors.
To assess the relationship between donor/recipient ABO blood type compatibility and graft failure due to rejection.
To assess corneal endothelial cell density as an indicator of the health of the cornea and as a alternate outcome measure (in an optional Specular Microscopy Ancillary Study).
Detailed description
The study enrolled 1101 subjects with a corneal disease considered to be at moderate risk for failure (principally Fuchs' dystrophy and pseudophakic corneal edema). A donor cornea meeting the following criteria was assigned to the subject by one of 43 participating eye banks:
- donor age 10 to 75 years
- endothelial cell count 2300 to 3300
- tissue quality very good to excellent
- death to preservation time <12 hrs if body refrigerated or eyes on ice and <8 hrs if not
- death to surgery time <5 days
The cornea surgeon (investigator) and patient were masked to donor age and characteristics of the donor cornea. Preoperative management, surgical technique, and postoperative care, including prescription of medications, were provided according to each investigator's customary routine. The follow-up visit schedule for the initial six months was left to each investigator's discretion and after this time the minimum follow-up visit schedule included a visit between six and 12 months and then one visit every 12 months through five years. The primary study outcome was graft survival at five years. The definition of graft failure, based on the definition used in Collaborative Corneal Transplantation Studies, was a regraft or, in the absence of regraft, a cloudy cornea in which there was loss of central graft clarity sufficient to compromise vision for a minimum of three consecutive months. Follow-up in the initial phase of the study continued for five years unless the patient had a regraft of the study eye.
For the ABO compatibility study, the ABO blood type of both the donor and recipient were determined in order to compare the rate of graft failure for ABO-compatible cases with the rate for ABO-incompatible cases.
For the Specular Microscopy Ancillary Study, endothelial cell counts were determined from specular images by a central reading center, and the relationship of the cell counts to donor age were assessed. In the initial phase of the study, specular images were obtained at 6 months, and then annually through five years post-transplant.
Five-year follow up was completed in November 2007. The 5-year cumulative probability of success was 86%: 86% in the <66.0 year donor age group and 86% in the >=66.0 year donor age group (difference = 0%, upper limit of one-sided 95% confidence interval = 4%). Adjusting for baseline endothelial cell density had no appreciable effect on these results. In a statistical model with donor age as a continuous variable, there was not a significant relationship between donor age and outcome (P=0.11). Three graft failures were due to primary donor failure, 8 to uncorrectable refractive error, 48 to graft rejection, 46 to endothelial decompensation, and 30 to other causes. At least one probable or definite graft rejection episode preceded graft failure in 23 of the 46 failures attributed to endothelial decompensation (4 definite and 19 probable) and in 18 of the 30 failures attributed to other causes (4 definite and 14 probable). The distribution of causes of failure between the donor age groups did not substantially differ.
Although the 5-year results indicated no difference in the success rate of moderate-risk transplants according to donor age, results from the SMAS indicated that among the successful cases, there was a slight association between donor age and endothelial cell loss, with the cell loss after 5 years being slightly lower in corneas from younger donors (r adjusted for baseline endothelial cell density = -0.19, 95% confidence interval -0.29 to -0.08). Whether this slight association between cell loss and donor age is of clinical importance is not known. Of perhaps even greater importance, however, was the finding that irrespective of donor age, endothelial cell loss was substantial over the first five years after transplant even when the graft had been successful. Half of the successful cases experienced a cell loss of 70% or more, and at five years more than half had an endothelial cell density <800 cells/mm2.
Patients in the CDS continued in annual follow up through 2012 in order to to determine the overall 10-year survival rate for moderate risk grafts and to determine whether the graft-failure rate is related to donor age. Additional objectives included determining the value of endothelial cell density in predicting graft failure and evaluating donor and recipient characteristics that may be predictive of late graft failure. All CDS subjects who were active at the 5-year exam were eligible for the extended follow-up phase.
As part of the Specular Microscopy Ancillary Study, follow-up images were obtained during the extended follow-up phase at 7-8 years and again at 10-years. The same procedures used during the first 5 years were followed for the grading of the 7-8 year and 10-year images.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: corneas assigned by donor age groupcornea assigned from donor age group <66.0 years |
| 2 | Active comparator | Other: corneas assigned by donor age groupcornea assigned from donor age group >= 66.0 years |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age range 40-80 years
- Corneal disease: Presence of a condition associated with endothelial dysfunction, including pseudophakic/aphakic corneal edema, Fuchs' dystrophy, posterior polymorphous dystrophy, interstitial keratitis (nonherpetic) or perforating corneal injury
- Willingness to be followed for 5 years and life expectancy at least 5 years (in investigator's judgement)
Key exclusion criteria (9 listed)
- Patients are to be excluded when there is:
- Uncontrolled glaucoma or prior filtering surgery with placement of a shunt in the eye to be grafted (Note: eyes requiring a filtering procedure combined with the PK are considered to have uncontrolled glaucoma and are ineligible. Eyes which have undergone filtering surgery (without a shunt) in which glaucoma is currently considered under control are eligible)
- Uncontrolled uveitis in the eye to be grafted
- Fellow eye visual acuity <20/200
- Fellow eye already included in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| corneas assigned by donor age groupA 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. | Other | 1, 2 |
Primary outcome
Graft Failure
Time frame: 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.
1 secondary outcome
Endothelial Cell Density (ECD)
Time frame: 10 year ECD
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10487423Beck RW, Gal RL, Mannis MJ, Holland EJ, Cavanagh HD, Foulks GN, Heck EL, Lindquist T, Macsai MS, Smith RE, Stark WJ, Stulting RD, Sugar J. Is donor age an important determinant of graft survival? Cornea. 1999 Sep;18(5):503-10. doi: 10.1097/00003226-199909000-00001. No abstract available.
- BackgroundPowe A, Gal RL, Beck RW, Mannis MJ, Holland EJ on behalf of the Cornea Donor Study Investigator Group. The Cornea Donor Study. Vision Pan-America 2009; 8:134-137.
- Results publication: PubMed 15829793Sugar A, Gal RL, Beck rW, Ruedy KJ, Blanton CL, Feder RS, Hardten DR, Holland EJ, Lass JH, Mannis MJ, O'Keefe MB; Cornea Donor Study Group. Baseline donor characteristics in the Cornea Donor Study. Cornea. 2005 May;24(4):389-96. doi: 10.1097/01.ico.0000151503.26695.f0.
- Results publication: PubMed 15745770Lass JH, Gal RL, Ruedy KJ, Benetz BA, Beck RW, Baratz KH, Holland EJ, Kalajian A, Kollman C, Manning FJ, Mannis MJ, McCoy K, Montoya M, Stulting D, Xing D; Cornea Donor Study Group. An evaluation of image quality and accuracy of eye bank measurement of donor cornea endothelial cell density in the Specular Microscopy Ancillary Study. Ophthalmology. 2005 Mar;112(3):431-40. doi: 10.1016/j.ophtha.2004.10.045.
- Results publication: PubMed 16371775Mannis MJ, Holland EJ, Beck RW, Belin MW, Goldberg MA, Gal RL, Kalajian AD, Kenyon KR, Kollman C, Ruedy KJ, Smith P, Sugar J, Stark WJ; Cornea Donor Study Group. Clinical profile and early surgical complications in the Cornea Donor Study. Cornea. 2006 Feb;25(2):164-70. doi: 10.1097/01.ico.0000164832.69668.4b.
- Results publication: PubMed 16603465Benetz BA, Gal RL, Ruedy KJ, Rice C, Beck RW, Kalajian AD, Lass JH; Cornea Donor Study Group. Specular microscopy ancillary study methods for donor endothelial cell density determination of Cornea Donor Study images. Curr Eye Res. 2006 Apr;31(4):319-27. doi: 10.1080/02713680500536738.
- Results publication: PubMed 18387407Cornea Donor Study Investigator Group; gal RL, Dontchev M, Beck RW, Mannis MJ, Holland EJ, Kollman C, Dunn SP, Heck EL, Lass JH, Montoya MM, Schultze RL, Stulting RD, Sugar A, Sugar J, Tennant B, Verdier DD. The effect of donor age on corneal transplantation outcome results of the cornea donor study. Ophthalmology. 2008 Apr;115(4):620-626.e6. doi: 10.1016/j.ophtha.2008.01.003.
- Results publication: PubMed 18387408Cornea Donor Study Investigator Group; Lass JH, Gal RL, Dontchev M, Beck RW, Kollman C, Dunn SP, Heck E, Holland EJ, Mannis MJ, Montoya MM, Schultze RL, Stulting RD, Sugar A, Sugar J, Tennant B, Verdier DD. Donor age and corneal endothelial cell loss 5 years after successful corneal transplantation. Specular microscopy ancillary study results. Ophthalmology. 2008 Apr;115(4):627-632.e8. doi: 10.1016/j.ophtha.2008.01.004.
- Results publication: PubMed 19395036Sugar A, Tanner JP, Dontchev M, Tennant B, Schultze RL, Dunn SP, Lindquist TD, Gal RL, Beck RW, Kollman C, Mannis MJ, Holland EJ; Cornea Donor Study Investigator Group. Recipient risk factors for graft failure in the cornea donor study. Ophthalmology. 2009 Jun;116(6):1023-8. doi: 10.1016/j.ophtha.2008.12.050. Epub 2009 Apr 23.
- Results publication: PubMed 19724216Sugar J, Montoya M, Dontchev M, Tanner JP, Beck R, Gal R, Gallagher S, Gaster R, Heck E, Holland EJ, Kollman C, Malling J, Mannis MJ, Woody J; Group Cornea Donor Study Investigator Group. Donor risk factors for graft failure in the cornea donor study. Cornea. 2009 Oct;28(9):981-5. doi: 10.1097/ICO.0b013e3181a0a3e6.
- Results publication: PubMed 19056078Dunn SP, Stark WJ, Stulting RD, Lass JH, Sugar A, Pavilack MA, Smith PW, Tanner JP, Dontchev M, Gal RL, Beck RW, Kollman C, Mannis MJ, Holland EJ; Cornea Donor Study Investigator Group. The effect of ABO blood incompatibility on corneal transplant failure in conditions with low-risk of graft rejection. Am J Ophthalmol. 2009 Mar;147(3):432-438.e3. doi: 10.1016/j.ajo.2008.09.021. Epub 2008 Dec 4.
- Results publication: PubMed 20065219Lass JH, Sugar A, Benetz BA, Beck RW, Dontchev M, Gal RL, Kollman C, Gross R, Heck E, Holland EJ, Mannis MJ, Raber I, Stark W, Stulting RD; Cornea Donor Study Investigator Group. Endothelial cell density to predict endothelial graft failure after penetrating keratoplasty. Arch Ophthalmol. 2010 Jan;128(1):63-9. doi: 10.1001/archophthalmol.2010.128.63.
- Individual participant dataSharing planned: Yes. Public dataset access: http://cds.jaeb.org/Studies.aspx?RecID=185
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward J Holland, MD study chair
University of Cincinnati and Cincinnati Eye Institute
Mark J Mannis, MD study chair
University of California, Davis
Roy W Beck, MD, PhD principal investigator
Jaeb Center for Health Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing corneas assigned by donor age group in people with Corneal Disease and Fuch's Dystrophy, run by National Eye Institute (NEI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft Failure (time frame: Baseline to 10 Years of Follow Up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006411, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.