AbstractPost-mortem donor eye tissues are essential for biomedical research. This study analyzes factors affecting donor eye availability for research through a retrospective review of recoveries at a U.S. eye bank between January 1, 2022, and December 31, 2023. Two time parameters were studied: death-to-recovery interval, defined as the time from death to tissue procurement, and post mortem interval (PMI), which accounts for the additional time required to transport tissue back to the laboratory for final preservation. The dataset was further stratified based on donor history for three ocular diseases frequently requested by researchers: age-related macular degeneration (AMD), glaucoma, and diabetic retinopathy. Among the eyes recovered specifically for research, only 32% of tissues met the < 12 h PMI requirement commonly requested by researchers. Further, only 27% of all research tissues meeting the < 12-hour PMI criterion arrived at the eye bank during current research staffing hours (8 AM–4 PM). The peak arrival time for research tissues was between 2 PM and 7 PM. The availability of tissues with PMI < 12 h further decreased for specific disease states. These findings highlight the logistical challenges of procuring donor eye tissues for research, particularly those with low PMIs. Adjustments by eye banks and researchers – such as extending staffing hours and relaxing strict PMI cutoffs – could significantly expand the donor pool for research. For example, if our eye bank extended research staffing by 3 h and researchers increased the allowable PMI to < 16 h, donor eye availability would increase by 223% over the current approach.
IntroductionHuman eye tissue is necessary for understanding the mechanisms underlying blinding disease and developing sight-saving therapies. Human derived cell lines and animal models of human disease are helpful for generating preliminary data1. However, cell lines can undergo molecular changes or become contaminated such that they do not accurately reflect the original tissue; and animal models may be insufficient as the animal biological/genomic response may vary from that of the human2. Some eye diseases, including primary open-angle glaucoma and age-related macular degeneration, are unique to humans and difficult to model in animals3,4,5. Further, with the recent advancement of precision medicine and gene therapy, where features of a disease and an individual patient are combined to develop highly targeted therapy, scientific studies with human tissues are required to characterize genetic changes and screen potential therapies1,6,7. Yet despite the consensus that human eye tissue is critical for visual science research, a survey of ARVO members reported that many researchers find it difficult to secure an adequate quantity of human eye tissue for their studies4. Our study provides one explanation for this limitation, focusing on the logistics of donor eye recovery.When transitioning from cell or animal models to human tissue for ocular research, differences in tissue procurement must be considered. Unlike animal tissue, which researchers can obtain on demand, human tissue availability is less controllable. Since most ocular research samples cannot be biopsied from living patients, researchers must partner with agencies that recover tissue from deceased donors. Eye banks are well-positioned and often willing to assist with this process. A survey of Eye Bank Association of America members found that many eye banks consider it ‘important’ or ‘very important’ for their institution to support the procurement of donor eyes for research8. Our eye bank, VisionGift (Portland, OR), has historically been willing to partner with research requests for ocular tissues, providing approximately 1200 ocular tissues for research and medical education in 2023.We have found that partner researchers, especially those focused on retinal disease research, routinely request ocular tissues with low (< 12 h) post-mortem interval (PMI), defined as the time between donor death and final tissue preservation (which is distinct from the time of recovery). This request criteria is based on the widely-held belief that longer PMI results in reduced integrity of DNA, RNA, and proteins9,10,11. This study analyzed recovery data and the research donor pool, considering eye bank logistics, recovery time, and PMI restrictions. By better understanding the details of donor ocular tissue recovery and preservation and identifying areas of potential change or flexibility in the process of acquiring ocular tissues for research, we hope to improve our capture of donated eye tissue frequently requested by researchers.ResultsAn overview of the ocular tissue recovery process and approximate timelines is shown in Fig. 1. The average time required to contact the legal next-of-kin (NOK) for research-specific recovery authorization was 7.0 h post-mortem (median: 5.5 ± 4.7 h, range: 0.3–29.1 h). The average death-to-recovery time was 12.6 h post-mortem (median: 11.5 ± 6.1 h, range: 2.1–37.7 h). The death-to-check-in interval — the time from donor death to tissue arrival in the laboratory for final preservation — is defined as the earliest possible post-mortem interval (PMI), is on average 17.0 h (median: 15.8 ± 8.2 h, range: 3.6–81.0 h).Fig. 1Summary of ocular tissue donation process. The ocular tissue donation process begins when the eye bank receives notification from the hospital of a potential donor’s death. The average time-to-completion of specific stages of this process are noted. NOK Next-of-kin.Full size imageDuring the study period, donor eyes were recovered specifically for research purposes from 896 distinct donors (2 eyes per donor). Of these, 868 donors (97%) have a death-to-recovery interval < 24 h and 734 (82%) have a PMI < 24 h (Fig. 2). The distribution of donor death-to-recovery interval and PMI in 4-hour intervals are shown in Fig. 2A. Eyes from 283 (32%) of donors had a PMI < 12 h. The number of donors recovered for research during current research staff hours (8 AM–4 PM) reduces tissue availability significantly. Donors with death-to-recovery < 24 h drop by 62% (from 868 to 329), and those with PMI < 24 h decrease by 63% (from 734 to 272).Fig. 2Tissue availability based on death-to-recovery interval and PMI. Number of research donors subdivided by 4-hour time intervals for death-to-recovery and death to check-in (PMI) from whom ocular tissues were recovered and returned to the VisionGift laboratory for final tissue preservation at (A) all hours and (B) during current research staffing hours of 8 a.m.–4 p.m. between January 1, 2022–December 31, 2023. The numbers above each bar represent the number of donors, and the numbers in parentheses (#) represents the percentage of the total indicated in the legend.Full size imageFor more restrictive timelines such as death-to-recovery < 12 h, the number of available donors were reduced by 68% (from 467 to 148), and for PMI < 12 h, the reduction was 73% (from 283 to 77) (Fig. 2B). The distribution of tissues with a death-to-recovery time or PMI of < 12 h is shown in Fig. 3. Our analysis shows that 32% of research donors with a death-to-recovery time of < 12 h and 27% of research donors with a PMI of < 12 h are captured during current research staffing hours (8 AM – 4 PM). Additionally, peak tissue procurement occurs between 2 PM and 7 PM, during which 32% of tissues are recovered within 12 h, and 23% of tissues arrive at the lab with a PMI of less than 12 h.Fig. 3Tissue availability based on death-to-recovery interval and PMI under 12 h. Distribution of arrival time at VisionGift for research donor tissue with death-to-recovery < 12 h and death to check-in (PMI) < 12 h. The black dashed box indicates ocular tissue that arrived during current research staffing hours (8 a.m.–4 p.m.). The yellow dashed box indicates peak tissue arrival time (2 p.m.–7 p.m.). The numbers above each bar represent the number of donors, and the numbers in parentheses (#) represents the percentage of the total indicated in the legend.Full size imageExamination of tissue procurement during an extended window (4 PM – 7 PM, three hours beyond current research staffing hours) revealed a marked increase in tissue capture for research (Fig. 4). For death-to-recovery times < 24 h, donor availability increased by 62% (205 donors), and for death-to-recovery times of < 12 h, it increased by 66% (97 donors). Similar increases were observed for PMI, with a 65% (176 donors) increase for PMI of < 24 h and an 86% (66 donors) increase for PMI of < 12 h.Fig. 4Increase in tissue availability with extended staffing hours. Number of research donors subdivided by 4-h time intervals for death-to-recovery and death-to-check-in (PMI) from whom tissues were recovered during current research staffing hours (8 a.m.–4 p.m.) and an extended window of 3 h that encompasses peak tissue arrival time (4 p.m.–7 p.m.).Full size imageOur analysis also reveals that a 4-hour extension of the death-to-recovery window (from < 12 to < 16 h) lead to an increase of 50% (74) more donors available for research (Fig. 4). Likewise, extending the PMI criterion from < 12 to < 16 h would add 78% (60) more donors. By both extending staffing hours and increasing the allowable death-to-recovery time, 141% (208) more donors would be captured over the current research staffing hours and < 12-hour restriction. Similarly, the extension of staffing hours along with increasing the allowable PMI to < 16 h results in an additional 223% (172) more donors.During the study period, eyes were recovered specifically for research from 59 donors with medically diagnosed AMD, 86 with glaucoma, and 33 with diabetic retinopathy. The death-to-recovery interval and PMI for these donors in 4-hour intervals are shown in Fig. 5. Donor availability is significantly reduced when final tissue preservation by research staff is required during current staffing hours (Fig. 6). When considering only death-to-recovery time, the number of available donors decreased by 63% (59 to 22) for AMD, 58% (86 to 36) for glaucoma, and 51% (33 to 16) for diabetic retinopathy. The reduction is even greater when considering PMI during research staffing hours with 69% (59 to 18) for AMD, 65% (86 to 30) for glaucoma, and 55% (33 to 15) for diabetic retinopathy.Fig. 5Availability of tissues from donors with ocular diseases. The number of research donors with ocular history of age-related macular degeneration (AMD), glaucoma, or diabetic retinopathy, subdivided by 4-hour time intervals for death-to-recovery and death-to-check-in (PMI), and returned to our laboratory for final tissue preservation at all hours of the day. The numbers above each bar represent the number of donors, and the numbers in parentheses (#) represents the percentage of the total indicated next to the disease name.Full size imageFig. 6Availability of tissues from donors with ocular diseases arriving to the laboratory during current research staffing hours (8 a.m.–4 p.m.). The number of research donors with ocular history of age-related macular degeneration (AMD), glaucoma, or diabetic retinopathy, subdivided by 4-h time intervals for death-to-recovery and death-to-check-in (PMI), and returned to our laboratory for final tissue preservation during current research staffing hours and an extended window of 3 h that encompasses peak tissue arrival time (4 p.m.–7 p.m.).Full size imageBy both extending death-to-recovery criteria to < 16 h and capturing tissue in a 3-hour extended window outside of current research staffing hours, availability of tissue would increase for donors with AMD by 91% (10 donors), with glaucoma by 95% (18 donors), and with diabetic retinopathy by 114% (8 donors). The same expansion of criteria for PMI, would see an increase of 200% (11 donors) with AMD, of 200% (18 donors) for donors with glaucoma, and 333% (10 donors) for those with diabetic retinopathy.DiscussionThe partnership between eye banks and researchers is critical, as much of the human tissue needed for ocular research cannot be biopsied from a living patient and must instead be obtained from a deceased donor. Procuring this tissue presents unique logistical and regulatory challenges. A better understanding of eye banking processes and donor tissue limitations will help set realistic expectations for researchers and eye bankers.In the U.S., eye banks follow the Uniform Anatomical Gift Act (UAGA), which permits self-authorization – commonly through the Department of Motor Vehicle (DMV) registry – for eye donation for therapeutic purposes, such as corneal transplantation, without requiring next-of-kin (NOK) authorization. However, non-therapeutic uses, such as biomedical research and medical education, are not always covered, and policies vary by state. For example, in Oregon, Washington, and Idaho, NOK authorization is required for research use, even if the tissue is deemed medically unsuitable for transplantation.There are two common ways to obtain ocular tissues for biomedical research. The first involves corneas recovered primarily for transplantation. If a cornea is later deemed unsuitable for transplantation, they can be used for research (with NOK authorization). In this scenario, however, often only the cornea was recovered, while posterior eye tissues – including the lens, retina, and RPE/choroid, which are often requested for research – remain unrecovered due to a lack of therapeutic applications.The second scenario, which is the focus of this research, involves recovering whole eyes or other ocular tissues under defined criteria specifically for research. If preliminary screening of the donor’s medical history indicates they are ineligible for ocular tissue donation for transplantation, our eye bank must legally obtain NOK authorization for research use. While recovering specifically for research allows for the targeted procurement and preservation of tissues in a predetermined manner, the additional steps in the donation process add complexity and can extend recovery and preservation timelines.The process of recovering tissue from a potential donor begins with the passing of an individual (Fig. 1). Upon notification of the eye bank by hospital staff that a death has occurred, the initial donor screening commences. This is intended to determine whether a decedent is eye donation eligible, and takes into consideration past and recent medical history, infection status, body location/tissue recovery logistics, and donor registry status. Once eye donation-eligibility is confirmed, and family members have left the body of the decedent, eye bank staff reach out to the potential donor’s legal NOK. Once NOK authorization has been received, a recovery technician can be dispatched, and donor eyes can be recovered. Donor eyes are then returned to the eye bank for final processing and preservation.NOK authorization for recovery of tissue to be used for research purposes is a required, delicate, and potentially time-consuming step (Fig. 1). At our eye bank, approaching the NOK for recovery authorization is deferred until the family has left the bedside of their deceased; and time that a grieving family wishes to spend with their deceased loved one is highly variable. Depending on the time of death, there may be an understandable delay in both notifying a family of a death and reaching the NOK for recovery authorization, as most people do not answer phone calls in the overnight or early morning hours. Additionally, the NOK is balancing the loss of a family member with numerous death-related tasks such as funeral arrangements and memorial plans; phone calls and voicemails regarding tissue donation can be missed or put off.Recovery staff availability and recovery logistics (body location, travel time, traffic delays) also impact donor tissue recovery time. Recovery staff may be assigned several cases in sequence (often without returning to the eye bank in between), technicians may need to travel long distances between cases, the donor body must be in a suitable location (with a sink, privacy, and still air) that recovery staff has access to, and tissues need to be driven back to the eye bank. For a donor who passes at around midnight, recovery authorization may not be granted until mid-morning, recovery may not occur until the afternoon, and tissue return to the eye bank may not happen until late afternoon or early evening. These realities are reflected in the peak arrival time for research tissue at our eye bank: 2PM – 7PM for tissues with death-to-recovery < 12 h, and 4PM – 7 PM for tissues with PMI < 12 h (Fig. 3).Another factor that influences the ability of an eye bank to procure eyes for research, especially those with low PMI, is that several eye banks rely on organ procurement organizations (OPOs) to recover eye tissue on their behalf. OPOs, responsible for recovering various organs and tissues, coordinating with hospitals and other facilities to retrieve donations from deceased individuals. Given the complexity and urgency of multi-organ recoveries, eyes are frequently not prioritized if there are other organs, such as heart or kidney, that require immediate attention for transplant viability. Additionally, OPOs work with strict protocols, schedules, and recovery location requirements, which can sometimes extend timelines beyond what eye banks might hope for. As a result, eye banks often depend on OPOs’ availability and coordination to receive donations, impacting the speed at which they can provide tissues for transplantation and research.An additional barrier in the provision of eyes for research, especially those with low PMI, is eye bank staffing. Although our eye bank operates 24 h a day, 7 days per week, only our call center and recovery staff operate on the 24/7 schedule; most other staff have regular “9 to 5” positions, including research staff who are responsible for final tissue processing and preservation. Of the 734 tissues with PMI < 24 h that arrived at our eye bank in the two-year period between January 1, 2022 and December 31, 2023, only 283 (39%) meet the PMI < 12-hour criteria requested by many vision research scientists (Fig. 2A). When staffing hours are considered, only 77 of these tissues meet the PMI < 12-hour request, a capture rate of approximately only 10% (Fig. 2B). These data are even more grim for researchers requesting tissues from donors who lived with particular diseases of interest: for a researcher studying diabetic retinopathy and requesting tissues with a PMI < 12 h, within current eye bank staffing constraints, only 3 tissues are available over a two-year period of time (Fig. 6).Based on our results, several practices could be considered that could result in capturing more research tissue, including adjustments to staffing hours. Under current practices, research staffing hours begin at 8AM and end at 4PM. When comparing this to tissue arrival time at the eye bank, it becomes apparent that current research staffing starts during a low tissue arrival time and ends mid-way through peak tissue arrival time, with research staffing and peak tissue arrival only overlapping by 2 h (Fig. 3). One consideration would be to shift research staff hours to 11AM – 7PM. This would result in complete coverage of peak tissue arrival and a 69% increase in PMI < 12-hour tissue capture. However, eye bank research staff tasks are not limited to final tissue processing and preparation, and morning office hours are currently occupied with other activities critical for providing researchers with tissue. Because our eye bank works with researchers across the US and worldwide, this early window of time is critical for important communication regarding availability of research tissue with research partners in other time zones.A second consideration for our eye bank is to increase research staffing hours to provide extended coverage during the 4:00 PM – 7:00 PM window. Expanding current staffing hours where dedicated research staff are present would result in an 86% increase in the capture of tissue with a PMI < 12 h. However, this approach would require additional research staff, and careful evaluation is needed to determine whether the associated increase in resource investment is economically viable.An extension of this consideration builds upon the continuous, 24/7/365 nature of eye banking operations and proposes that eye banks prioritize research tissue procurement in a manner similar to their clinical corneal transplantation practices. While theoretically feasible, implementing such a change would increase operational costs for eye banks. To offset these costs, eye banks would need to raise fees for research tissue procurement, which currently accounts for only a small fraction (approximately 10 – 20% at our eye bank) of the fees associated with clinical transplantation tissues. Achieving cost parity with transplant grafts would require significant adjustments and collaboration between eye banks and researchers. This decision cannot be made unilaterally; rather, it necessitates ongoing dialogue between eye banks and the research community. Our current work aims to facilitate this dialogue, ensuring that eye banks can support researchers in procuring the necessary tissues while maintaining financial sustainability.A third consideration our eye bank is currently evaluating is training our recovery technicians to perform basic tissue preservation upon returning to the laboratory, independent of research staff presence. Examples include eye or tissue fixation using formalin, simple dissections followed by formalin fixation, or freezing the samples with dry ice or LN2 available in our laboratory. This approach would provide researchers requiring formalin-fixed tissues or simple dissections with greater access to samples with shorter PMIs.While this operational change may be relatively straightforward for formalin fixation and other simple preservation methods, implementing similar protocols for more involved procedures would be far more complex. The diversity of tissue dissections and preservation protocols – each requiring different specific reagents and buffers requested by researchers – makes technician training significantly more challenging. Eye banks must also consider the resources required to implement such operational additions. Additionally, this approach only works if the technician does not have another recovery case lined up, which is often the case, as discussed above.Tissue availability is further constrained by researcher-specified inclusion and exclusion criteria. Some of these criteria are inflexible, as disease state, recent medical history, and cause-of-death can significantly affect tissue integrity. However, extending the allowable PMI may partially mitigate these limitations and increase the pool of available donor tissues. Currently, a PMI of < 12 h is the most commonly requested by researchers, largely based on incomplete or flawed data regarding biomolecule degradation over time9,10,11. Ongoing research in our laboratory aims to assess molecular changes – specifically DNA, RNA, and protein integrity – in the retina as a function of post-mortem time, while accounting for standard eye banking practice. If these biomolecules are found to remain intact up to 16 h post-mortem (PMI ≤ 16), the availability of research tissue from our eye bank would increase by 78% (from 77 to 137 donors) within the 4-hour window between 12 and 16 h under current staffing practices (8:00 AM – 4:00 PM).In this study, we distinguish between death-to-recovery interval and earliest possible post-mortem interval (PMI). Death-to-recovery refers to the time from a donor’s death to ocular tissue recovery in the field. Researchers using whole eyes or corneas that can be fixed or preserved immediately may rely on this interval to estimate tissue availability. In contrast, those requiring complex dissections or lab-based processing should refer to the PMI data. Researchers should consider their specific preservation needs when interpreting these intervals.Limitations of this study include the use of data from a single eye bank that procures tissue specifically for research. While minor differences exist between eye banks, the donation process in the U.S. is highly regulated, and our timelines are likely representative of the few eye banks offering prospective post-mortem donor eye collection for research. Another limitation is that our data considers only PMI as a factor limiting tissue availability. Researchers, especially those seeking retinal tissue, often decline samples from donors with sepsis at death, recent chemotherapy, or diabetes due to potential impacts on tissue integrity and confounding variables. Accounting for these exclusion criteria would further restrict the available donor pool.This study of eye banking recovery processes and recovery data on tissues specifically designated for research purposes at our eye bank provides evidence of the relatively small pool of eye tissue available for research. Eye banks can examine the data presented here to examine their own processes and potentially adjust current practices to allow for increased capture of research-appropriate tissue. Researchers can use this information to estimate donor tissue availability for their work. Further research is needed regarding the degradation of small biomolecules in ocular tissue, as the widely held belief that DNA, RNA, and protein degrade significantly 12 h post-mortem is the basis for requests for low PMI tissue. By taking all these factors into consideration and making adjustment where possible, a greater number of research tissues will be provided to scientists, thereby advancing our understanding of mechanisms underlying healthy and diseased eyes.MethodsThis retrospective record review of donor ocular tissues recovered for research by VisionGift (Portland, OR) between January 1, 2022 and December 31, 2023 was performed using an institutional review board-monitored, Health Insurance Portability and Accountability Act-compliant, electronic tissue management database (InSight, Version 2024.35). Data for donor date and time of death, tissue recovery time, arrival time at the eye bank, and ocular disease history were extracted.Death-to-recovery time is defined as the time elapsed between a donor’s death and recovery of their ocular tissues. Death to check-in time is defined as the time elapsed between a donor’s death and return of their ocular tissues to the eye bank for final processing/preservation steps. In our study, we use death to check-in time to estimate the earliest possible post-mortem interval (PMI) in which recovered eye tissues can undergo final dissection and preservation or tissue culturing according to a protocol specified by a collaborator. In the majority of the requests we received from our collaborators, the PMI represents a critical criterion for tissue collection and preservation for their downstream assays.All time stamps were exported from our database and time intervals were calculated using Microsoft Excel (Microsoft Office 365, Version 2402, Build 16.0.17328.20124). The resultant data set was analyzed for tissue arrival time at the eye bank during the entire 24 h of the day and during current work hours of 8AM − 4PM when dedicated research staff are available to perform tissue dissections, cell/tissue culturing, or other final preservation steps. Finally, the data set was analyzed for donor history of three common ocular diseases for which tissues are frequently requested by researchers: age-related macular degeneration (AMD), glaucoma, and diabetic retinopathy. Disease states were confirmed using the donor’s medical records.
Data availability
All data that support the findings of this study are available from the corresponding author, KDT, upon reasonable request.
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Download referencesAcknowledgementsThe authors would like to thank organ, eye, and tissue donors and their families for providing ocular tissues for research that contributes towards preventing and curing blindness. This work was partially funded by a research grant to K.D.T from the Eppley Foundation for Research.Author informationAuthors and AffiliationsVisionGift, 2201 SE 11th Avenue, Portland, OR, 97214, USAMegan M. W. Straiko, Mark S. Ellison, Corrina Patzer, Kody Westrick & Khoa D. TranAuthorsMegan M. W. StraikoView author publicationsYou can also search for this author in
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PubMed Google ScholarContributionsMMWS: Performed the research, validated data and analysis, wrote the manuscript, and reviewed and edited the manuscript. MSE: Wrote the manuscript, and reviewed and edited the manuscript. CP: Wrote the manuscript, and reviewed and edited the manuscript. KW: Wrote the manuscript, and reviewed and edited the manuscript. KDT: Conceptualized the study and designed methodology. Validated data and analysis, wrote the manuscript, and reviewed and edited the manuscript. Provided supervision, resources, and secured funding.Corresponding authorCorrespondence to
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KeywordsDonor eyes for researchOcular tissues procurementPostmortem intervalDeath-to-recovery interval, eye banking