Cornea Donor Study

NCT00006411 | Completed Results DMC

• 4 other identifiers: NEI-805U10EY0123583U10EY012358-11S15U10EY012728
• Study Type: interventional
• Target: 1,090
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Corneal Disease; Fuch's Dystrophy; Pseudophakic Corneal Edema

Keywords

cornea transplant; corneal endothelial cell density; moderate risk corneal diseases; corneal transplantation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 10 Years of Follow Up

Secondary Outcomes (1)

• Endothelial Cell Density (ECD)

  10 year ECD

Study Arms (2)

1

ACTIVE COMPARATOR

cornea assigned from donor age group \<66.0 years

Other: corneas assigned by donor age group

2

ACTIVE COMPARATOR

cornea assigned from donor age group \>= 66.0 years

Other: corneas assigned by donor age group

Interventions

corneas assigned by donor age group 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.

1; 2

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• Uncontrolled uveitis in the eye to be grafted
• Fellow eye visual acuity \<20/200
• Fellow eye already included in the study

Sponsors & Collaborators

• National Eye Institute (NEI): lead
• Eye Bank Association of America: collaborator
• Bausch & Lomb Incorporated: collaborator
• Tissue Banks International: collaborator
• Vision Share, Inc.: collaborator
• San Diego Eye Bank: collaborator
• The Cornea Society: collaborator
• Katena Products, Inc.: collaborator
• ViroMed Laboratories, Inc.: collaborator
• Midwest Eye Banks: collaborator
• Konan Medical, Inc.: collaborator
• Eye Bank for Sight Restoration: collaborator
• SightLife: collaborator
• Sight Society of Northeastern New York (Lions Eye Bank of Albany): collaborator
• Lions Eye Bank of Oregon: collaborator

Study Sites (1)

Jaeb Center for Health Research, Inc.

Tampa, Florida, 33647, United States

Location

Related Publications (23)

• 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.

  PMID: 10487423 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.

  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.

  PMID: 15829793 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.

  PMID: 15745770 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.

  PMID: 16371775 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.

  PMID: 16603465 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.

  PMID: 18387407 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.

  PMID: 18387408 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.

  PMID: 19395036 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.

  PMID: 19724216 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.

  PMID: 19056078 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.

  PMID: 20065219 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.

  PMID: 21555600 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.

  PMID: 22488114 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.

  PMID: 22262218 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.

  PMID: 23343949 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.

  PMID: 23493999 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.

  PMID: 24246825 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.

  PMID: 24246826 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.

  PMID: 25119961 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.

  PMID: 25425307 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.

  PMID: 25322173 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.

  PMID: 25439611 RESULT

MeSH Terms

Conditions

Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Roy W. Beck, MD, PhD
• Organization: JCHR

cds@jaeb.org

813-975-8690

Study Officials

• Edward J Holland, MD

  University of Cincinnati and Cincinnati Eye Institute

  STUDY CHAIR

• Mark J Mannis, MD

  University of California, Davis

  STUDY CHAIR

• Roy W Beck, MD, PhD

  Jaeb Center for Health Research

  PRINCIPAL INVESTIGATOR

• Jonathan H Lass, MD

  (PI of Specular Microscopy Ancillary Study), Case Western Reserve University and University Hospitals Case Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2000
• First Posted: October 16, 2000
• Study Start: January 10, 2000
• Primary Completion: December 31, 2012
• Study Completion: July 1, 2014
• Last Updated: February 25, 2020
• Results First Posted: February 25, 2020

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)