Study of Death to Preservation Time and Its Impact on Quality & Utilization of Donor Corneas PBN: 275-085 SN: 225 Dhaval Patel1, Radhika Tandon1, Aarti Vij2, Sanjeev Lalwani, Adarsh Kumar Dr R P Centre for Ophthalmic Sciences1, Organ Retrieval & Banking Organization2, All India Institute of Medical Sciences, New Delhi, India PURPOSE To study the effects of death to preservation time on quality and utilization of donor corneas. BACKGROUND Corneal Blindness: INDIA1 3.5 million people Need = 100,000 Keratoplasty/ year Collection = 47,400 in 2012 Every year, supply of suitable donor corneas cannot meet the demand because donor tissue is often rejected for the reason of “long cadaveric time.” MATERIALS & METHODS Study Design: Prospective Observational Study Study Site: National Eye Bank, AIIMS Study Period: November 2011 to January 2013. We evaluated Donor Corneas by Standard Grading System adapted & modified from Cornea Donor Study (NEI 2002-2013) Tissue Eligibility Criteria. 2 Parameters evaluated included donor age, gender, history of diabetes, lens status, type of retrieval and type of donation, corneal grading, endothelial cell density, and primary graft failure & graft infection in first 4 weeks after transplantation. Corneal parameters like epithelial defect, haze, exposure, stromal edema, descemet’s folds, grade, and ECD were compared in five intervals of DPT i.e. 0-6, 6-9, 9-12, 12-18, and >18 hours. Effect of donor refrigeration prior to tissue retrieval was evaluated. RESULTS Death to Preservation Time Mean DPT: 6:50 ± 5:50 hours (Range: 20 minutes to 28 hours) DPT and Corneal Grading   DPT Total 0-5:59 6:00-8:59 9:00-11:59 12:00-17:59 ≥ 18:00 P value (Pearson Chi-Square) n=1092 n=616 n=160 n=111 n=155 n=50 Optical 38% 34% 43% 39% 45% 54% 0.05  Grading Therapeutic 57% 61% 52% 40% NSFS 5% 4% 3% 6% 0-1499 10% 0.51 ECD 1500-1999 29% 27% 30% 33% 32% 24% >=2000 66% 69% 60% 62% 65% 71% Donor Characteristics DPT and Refrigeration Donor Characteristics N (%)   HCRP VD Total Age (years) 0-29 94 (16.3) 7 (1.2) 101 (17.5) 30-59 106 (18.4) 29 (5.1) 135 (23.5) >=60 57 (9.9) 282 (49.1) 339 (59) Median 65 years Mean ± SD 58.72 ± 23.12 Gender Male 176 (30.6) 175 (30.4) 351 (61) Female 81 (14.1) 143 (24.9) 224 (39) History of Diabetes Yes 24 (4.2) 31 (5.4) No 250 (43.5) 294 (51.1) 544 (94.6) Lens Status Phakic 955 (83.8) Pseudophakic 155 (16) Aphakic 2 (0.2)   DPT & DONOR REFRIGERATION 0-5:59 6:00-11:59 ≥ 12:00 Refrigeration No Yes P value n=590 n=26 n=217 n=54 n=109 n=96 Grading Optical 198 11 0.372 73 38 <0.001 33 63 Therapeutic 361 15 130 16 71 30 NSFS 31 14 5 3   DPT & DONOR REFRIGERATION 0-5:59 6:00-11:59 ≥ 12:00 No Yes P value n=241 n=16 n=107 n=25 n=59 n=58 ECD 0-1499 11 0.245 9 1 0.412 4 <0.001 1500-1999 67 2 36 6 26 8 >=2000 166 14 62 18 29 50 Donor Characteristics P value Grade ECD Culture Primary Graft Failure Graft Infection Age <0.001 0.001 0.2268 0.611 0.715 Gender 0.326 0.086 0.239 0.16 Diabetes <0.01 0.138 0.451 0.527 0.346 Lens Status 0.003 0.725 0.694 Enucleation/In-situ 0.007 0.097 0.373 0.8 HCRP/VD 0.09 0.328 0.703 Other Parameters Death to Utilization Time Mean death to utilization time (DUT) was 2.3 days. Utilization rate was similar in all intervals of DPT. DUT was not related to primary graft failure (p=0.54) but was related to graft infection (p=0.001).  Donor Characteristics Corneal Grading/ ECD Age Age has Inverse relationship with Grading & ECD.(p<0.001,p=0.001) Gender Male Corneas have better grading than that of Females (p<0.001) Diabetes Non-diabetic Donors have better Grading than Diabetic (p<0.01) Lens Status Phakic Eye has better grading and ECD that Pseudophakic. (p<0.001,p=0.003) Enucleation/ In-situ In-situ technique has better grading & ECD than Enucleation. (p=0.005,p=0.007) HCRP/VD HCRP donors have better grading & ECD than Voluntary Donors. (p<0.001,p=0.001) Prolonged DPT had significant effect on Donor Culture Positivity (p=0.001).   Primary graft failure and graft infection rate was 1.9% & 4.9% in optical grade corneas and 1.3% & 10.4% in therapeutic grade corneas respectively. Up to duration of 28 hours, DPT was not related to Primary Graft Failure (p=0.131) and Graft Infection (p=0.137) in first 4 weeks of Transplantation. CONCLUSIONS There is no correlation between death preservation time (DPT) and donor cornea quality in our study range 20 minutes to 28 hours provided donor is refrigerated in case of DPT more than 6 hours . Donor Characteristics having impact on Cornea Quality are Age, Gender, Diabetes, Lens Status, Type of Retrieval and HCRP-Voluntary Donation. DPT has no significant effect on rate of utilization of donor cornea. REFERENCE NPCB Statistics Report 2012-2013 Baseline Donor Characteristics in the Cornea Donor Study, Cornea 2005;24:389–396 ABBREVIATIONS DPT: Death Preservation Time ECD: Endothelial Cell Density HCRP: Hospital Cornea Retrieval Program NSFS: Not Suitable For Surgery VD: Voluntary Donation Asia ARVO New Delhi, October 28-31, 2013