Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
1090 participants
Study Classification
INTERVENTIONAL
Study Start Date
2000-01-10
Study Completion Date
2014-07-31
Brief Summary
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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).
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).
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Detailed Description
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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.
* 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.
Conditions
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Corneal Disease
Fuch's Dystrophy
Pseudophakic Corneal Edema
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
OTHER
Blinding Strategy
TRIPLE
Participants
Investigators
Outcome Assessors
Study Groups
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1
cornea assigned from donor age group \<66.0 years
Group Type
ACTIVE_COMPARATOR
corneas assigned by donor age group
Intervention Type
OTHER
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.
2
cornea assigned from donor age group \>= 66.0 years
Group Type
ACTIVE_COMPARATOR
corneas assigned by donor age group
Intervention Type
OTHER
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.
Interventions
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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.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
1. Age range 40-80 years
2. 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
3. Willingness to be followed for 5 years and life expectancy at least 5 years (in investigator's judgement)
Exclusion
1. 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
2. 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)
3. Uncontrolled uveitis in the eye to be grafted
4. Fellow eye visual acuity \<20/200
5. Fellow eye already included in the study
2. 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
3. Willingness to be followed for 5 years and life expectancy at least 5 years (in investigator's judgement)
Exclusion
1. 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
2. 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)
3. Uncontrolled uveitis in the eye to be grafted
4. Fellow eye visual acuity \<20/200
5. Fellow eye already included in the study
Minimum Eligible Age
40 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eye Bank Association of America
OTHER
Sponsor Role
collaborator
Bausch & Lomb Incorporated
INDUSTRY
Sponsor Role
collaborator
Tissue Banks International
UNKNOWN
Sponsor Role
collaborator
Vision Share, Inc.
INDUSTRY
Sponsor Role
collaborator
San Diego Eye Bank
OTHER
Sponsor Role
collaborator
The Cornea Society
OTHER
Sponsor Role
collaborator
Katena Products, Inc.
INDUSTRY
Sponsor Role
collaborator
ViroMed Laboratories, Inc.
INDUSTRY
Sponsor Role
collaborator
Midwest Eye Banks
OTHER
Sponsor Role
collaborator
Konan Medical, Inc.
INDUSTRY
Sponsor Role
collaborator
Eye Bank for Sight Restoration
UNKNOWN
Sponsor Role
collaborator
SightLife
OTHER
Sponsor Role
collaborator
Sight Society of Northeastern New York (Lions Eye Bank of Albany)
UNKNOWN
Sponsor Role
collaborator
Lions Eye Bank of Oregon
UNKNOWN
Sponsor Role
collaborator
National Eye Institute (NEI)
NIH
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Edward J Holland, MD
Role: STUDY_CHAIR
University of Cincinnati and Cincinnati Eye Institute
Mark J Mannis, MD
Role: STUDY_CHAIR
University of California, Davis
Roy W Beck, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Jaeb Center for Health Research
Jonathan H Lass, MD
Role: PRINCIPAL_INVESTIGATOR
(PI of Specular Microscopy Ancillary Study), Case Western Reserve University and University Hospitals Case Medical Center
Locations
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Jaeb Center for Health Research, Inc.
Tampa, Florida, United States
Site Status
Countries
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United States
References
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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.
Reference Type
BACKGROUND
Powe 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.
Reference Type
BACKGROUND
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.
Reference Type
RESULT
Lass 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.
Reference Type
RESULT
Mannis 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.
Reference Type
RESULT
Benetz 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.
Reference Type
RESULT
Cornea 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.
Reference Type
RESULT
Cornea 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.
Reference Type
RESULT
Sugar 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.
Reference Type
RESULT
Sugar 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.
Reference Type
RESULT
Dunn 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.
Reference Type
RESULT
Lass 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.
Reference Type
RESULT
Lass 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.
Reference Type
RESULT
Stulting 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.
Reference Type
RESULT
Sugar 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.
Reference Type
RESULT
Verdier DD, Sugar A, Baratz K, Beck R, Dontchev M, Dunn S, Gal RL, Holland EJ, Kollman C, Lass JH, Mannis MJ, Penta J; Cornea Donor Study Investigator Group. Corneal thickness as a predictor of corneal transplant outcome. Cornea. 2013 Jun;32(6):729-36. doi: 10.1097/ICO.0b013e31827b14c7.
Reference Type
RESULT
Benetz BA, Lass JH, Gal RL, Sugar A, Menegay H, Dontchev M, Kollman C, Beck RW, Mannis MJ, Holland EJ, Gorovoy M, Hannush SB, Bokosky JE, Caudill JW; Cornea Donor Study Investigator Group. Endothelial morphometric measures to predict endothelial graft failure after penetrating keratoplasty. JAMA Ophthalmol. 2013 May;131(5):601-608. doi: 10.1001/jamaophthalmol.2013.1693.
Reference Type
RESULT
Writing Committee for the Cornea Donor Study Research Group; Mannis MJ, Holland EJ, Gal RL, Dontchev M, Kollman C, Raghinaru D, Dunn SP, Schultze RL, Verdier DD, Lass JH, Raber IM, Sugar J, Gorovoy MS, Sugar A, Stulting RD, Montoya MM, Penta JG, Benetz BA, Beck RW. The effect of donor age on penetrating keratoplasty for endothelial disease: graft survival after 10 years in the Cornea Donor Study. Ophthalmology. 2013 Dec;120(12):2419-2427. doi: 10.1016/j.ophtha.2013.08.026.
Reference Type
RESULT
Writing Committee for the Cornea Donor Study Research Group; Lass JH, Benetz BA, Gal RL, Kollman C, Raghinaru D, Dontchev M, Mannis MJ, Holland EJ, Chow C, McCoy K, Price FW Jr, Sugar A, Verdier DD, Beck RW. Donor age and factors related to endothelial cell loss 10 years after penetrating keratoplasty: Specular Microscopy Ancillary Study. Ophthalmology. 2013 Dec;120(12):2428-2435. doi: 10.1016/j.ophtha.2013.08.044.
Reference Type
RESULT
Dunn SP, Gal RL, Kollman C, Raghinaru D, Dontchev M, Blanton CL, Holland EJ, Lass JH, Kenyon KR, Mannis MJ, Mian SI, Rapuano CJ, Stark WJ, Beck RW; Writing Committee for the Cornea Donor Study Research Group. Corneal graft rejection 10 years after penetrating keratoplasty in the cornea donor study. Cornea. 2014 Oct;33(10):1003-9. doi: 10.1097/ICO.0000000000000212.
Reference Type
RESULT
Riddlesworth TD, Kollman C, Lass JH, Patel SV, Stulting RD, Benetz BA, Gal RL, Beck RW. A mathematical model to predict endothelial cell density following penetrating keratoplasty with selective dropout from graft failure. Invest Ophthalmol Vis Sci. 2014 Nov 25;55(12):8409-15. doi: 10.1167/iovs.14-15683.
Reference Type
RESULT
Writing Committee for the Cornea Donor Study Research Group; Sugar A, Gal RL, Kollman C, Raghinaru D, Dontchev M, Croasdale CR, Feder RS, Holland EJ, Lass JH, Macy JI, Mannis MJ, Smith PW, Soukiasian SH, Beck RW. Factors associated with corneal graft survival in the cornea donor study. JAMA Ophthalmol. 2015 Mar;133(3):246-54. doi: 10.1001/jamaophthalmol.2014.3923.
Reference Type
RESULT
Lass JH, Riddlesworth TD, Gal RL, Kollman C, Benetz BA, Price FW Jr, Sugar A, Terry MA, Soper M, Beck RW; Cornea Donor Study Research Group. The effect of donor diabetes history on graft failure and endothelial cell density 10 years after penetrating keratoplasty. Ophthalmology. 2015 Mar;122(3):448-56. doi: 10.1016/j.ophtha.2014.09.012. Epub 2014 Nov 15.
Reference Type
RESULT
Other Identifiers
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ACTIVE_NOT_RECRUITING
Outcome After Descemet Membrane Endothelial Keratoplasty (DMEK) and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
NCT02020044
UNKNOWN
NA
Collaborative Corneal Transplantation Studies (CCTS)
NCT00000137
COMPLETED
PHASE3
Effect of Intracorneal Ring Segments on Posterior Corneal Tomography in Eyes With Keratoconus
NCT04748198
COMPLETED
NA
Prospective Randomized Study Comparing Endothelial Cell Loss Using the Tan EndoGlide With Forceps for Insertion of the Donor Graft in DSAEK
NCT01284101
UNKNOWN
NA
Corneal Biomechanics, Optical Properties and Anterior Segment Structural Features in Patients With Pseudoexfoliation
NCT06731530
RECRUITING
Corneal Thickness Changes During Corneal Collagen Cross-linking With Ultraviolet-A Irradiation and Riboflavin
NCT01485211
COMPLETED
PHASE4
Evaluation of the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL Intraocular Lens
NCT00838045
COMPLETED
PHASE4
Corneal Endothelial Cell Density in Eyes Treated With a Fluocinolone Acetonide Intravitreal Implant
NCT03145025
COMPLETED
Safety and Effectiveness of the AcuFocus Corneal Inlay ACI7000PDT in Presbyopes
NCT01352442
COMPLETED
NA
Prospective Study of Deep Anterior Lamellar Keratoplasty Using Acellular Porcine Cornea
NCT03105466
UNKNOWN
NA
Vision Restoration With a Collagen Crosslinked Boston Keratoprosthesis Unit
NCT02863809
COMPLETED
PHASE1/PHASE2
Evaluation of Corneal Hysteresis and Corneal Resistance Factor After Corneal Cross-linking for Keratoconus
NCT01411384
COMPLETED
NA
Descemet Endothelial Thickness Comparison Trial
NCT02373137
UNKNOWN
PHASE4