BACKGROUND:Neuromyelitis optica spectrum disorders (NMOSD) and myelin oligodendrocyte glycoprotein antibody disease (MOGAD) are autoimmune inflammatory disorders of the central nervous system. Central serous chorioretinopathy (CSCR) is characterized by a serous retinal detachment with leakage of fluid through the retinal pigment epithelium accumulating under the retina. This study investigated a potential association between CSCR and these neuroinflammatory disorders. METHODS:We included people with aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive NMOSD (N = 39), multiple sclerosis (MS, N = 39), myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD, N = 13), seronegative NMOSD (SN-NMOSD, N = 9), and healthy controls (HC, N = 30). Using optical coherence tomography (OCT), we assessed CSCR frequency and the thickness of the peripapillary retinal nerve fiber layer (pRNFL). RESULTS:There was a higher CSCR frequency (21.3%) throughout all investigated subgroups (AQP4-IgG seropositive NMOSD, MOGAD, and SN-NMOSD) than in the HC group (p = 0.048), with a significant association between CSCR and arterial hypertension frequency but not with these diagnoses, retinal neuroaxonal loss, or history of optic neuritis. CONCLUSION:The high frequency of CSCR suggests a potential benefit of routine monitoring of CSCR in patients with NMOSD and MOGAD using the OCT technology, a reliable method to detect and monitor CSCR in patients with neuroinflammatory disorders. Further research is necessary to establish the underlying pathophysiology and potential effects on vision.

Die Sektion Gewebetransplantation und Biotechnologie der Deutschen Ophthalmologischen Gesellschaft (DOG) publiziert seit 2009 regelmäßig die freiwillig angegebenen Leistungszahlen der assoziierten Augenhornhautbanken [1], [2], [3], [4], [5], [6], [7], [8], [9], [10], [11]. Seit 2016 sind 26 Augenhornhautbanken in der Sektion organisiert ([Tab. 1]).

ZusammenfassungDie Sektion Gewebetransplantation und Biotechnologie der Deutschen Ophthalmologischen Gesellschaft (DOG) legt ihren 11. Leistungsbericht des Jahres 2021 vor. Die Anzahl der eingeworbenen Augenhornhäute ist im Vergleich zu den Vorjahren leicht ansteigend. Dennoch besteht immer noch ein Bedarf für Import aus dem Ausland, somit ist der Transplantatengpass immer noch nicht beseitigt.

The Section on Tissue Transplantation and Biotechnology of the German Ophthalmologic Society presented its 11th annual report for the year 2021. The number of corneal samples has still risen in comparison to former years. Nevertheless, there is still a need for import of transplants from abroad. Therefore, the transplant bottleneck has not yet been eliminated.

Introduction Since the beginning of the COVID-19 pandemic there has been some debate regarding the risk of transmission through tissue transplantation and tissue banking processes. Aim of the study To analyze the changes that SARS-CoV-2 has caused regarding the harvesting of corneal donor tissue and eye bank activities in Germany. Methods A questionnaire was provided to 26 eye banks in Germany, consisting of questions about adaptations made in the screening of potential donors and the harvesting of corneal tissue following the pandemic spread of SARS-CoV-2. Results Eighteen eye banks actively reduced recruitment of donors and two banks ceased all activity. Additional diagnostic screening was performed in eight banks, using conjunctival swabs and/or nasopharyngeal swabs. In six eye banks, additional protective measures, such as FFP2 masks and/or facial shields, were implemented. Overall, a mean reduction in the number of obtained donor tissues of 17% was observed. Discussion Conjunctival and/or nasopharyngeal swabs of donors have been implemented by a minority. Reasons for not performing additional tests may be moderate sensitivity and lack of validation for postmortem use of RT-PCR testing. Also, the hazard of SARS-CoV-2 entering the corneal donor pool with subsequent transmission might be perceived as theoretical. Face shields provide a sufficient barrier against splash and splatter contamination but may be insufficient against aerosols. Additional face masks would provide support against aerosols, but it remains debatable if corneal harvesting can be considered an aerosol-producing procedure. In the future we expect to see changes in current guidelines because of a surge in scientific activities to improve our understanding of the risks involved with cornea donation in the COVID-19 pandemic, and because current practice may reduce the availability of donor corneas due to new exclusion criteria while the demand remains unchanged.

Tissue transplants are of continuing high importance for patient care. As with all transplanted material of human origin, tissue transplants carry risks of disease transmission which must be controlled by the application of stringent donor selection criteria and comprehensive quality systems. On the one hand, against the background of an ageing population in Europe, there is an increasing need for tissue transplants. On the other hand, there is already a relative shortage for many tissue transplants. It is therefore necessary to define donor selection criteria carefully but also critically. In particular, the maximum acceptable post-mortem time interval is an important parameter here. In the present special issue, some of these currently discussed questions were investigated and proposals for scientific-based answers provided. Serological or molecular genetic tests for infectious diseases (HIV, hepatitis B and C) are mandatory and are carried out routinely. In some cases, post-mortem blood is the only available sample for the diagnostic. Although a large number of the laboratory tests used today have been validated for post-mortem blood, a characterization of the blood samples used for this purpose is not yet defined. Larscheid et al. [1] have therefore examined the immunoglobulin G (IgG) content in the post-mortem blood of tissue donors in comparison with the value of the ante-mortal blood sample. The total IgG values in antemortal samples were below the lower limit of 6 g/l in 20% of the cases. Additionally, the total IgG was also significantly lower in the post-mortem samples compared to the ante-mortal samples. A correlation with the post-mortem time could not be found. Low IgG levels could therefore limit the validity of post-mortem blood for infection serological tests. The findings underline the importance of additional NAT tests. For tissues that cannot undergo a sterilization process, e.g. corneal transplants, microbiological safety plays an essential role in protecting the recipient. Here, sensitive testing methods and a risk-adapted testing strategy are essential. The European Pharmacopoeia provides detailed guidelines, but their specific implementation in tissue banks was and is the subject of scientific studies. Herrlinger et al. [2] investigated in the presented validation study different incubation temperatures in a semi-automated system with blood culture bottles. 35 ° C showed to be the incubation temperature with the fastest growth of the majority of the test strains used and a complete detection within 14 days. It is important for tissue banks to optimize their microbiological testing strategies for human pathogenic microorganisms, but also for potentially pathogenic contaminants in the context of tissue explantation. This is not without problems, as sensitive semiautomated systems for low incubation temperatures between 20 and 25 ° C are not available. Given the large spectrum of tissue transplants available, further studies on this topic will certainly be useful in the future. The realization of tissue donations is bonded to a tight timeframe. Depending on the type of tissue, deadlines are set to prevent a loss of tissue quality with increasing time intervals. According to the applicable regulations (EDQM guidelines, Guidelines of the German Medical Association), corneas must be explanted within 72 h after death. Hofmann et al. [3] asked themselves whether this time interval has an influence on the quality of the transplant-

Background: A serology testing for infectious diseases (HIV, hepatitis B and C, syphilis) is mandatory in tissue donors. In many donors postmortem blood is the only sample available. Even though serological tests and nucleic acid amplification tests (NAT) used are validated for postmortem blood, a characterization of those blood samples is not yet established. We therefore investigated the total immunoglobulin G (IgG) content in postmortem blood of tissue donors and compared it to a corresponding antemortem blood sample. Methods: Ante- and postmortem blood samples were obtained from 100 consecutive tissue donors. The total IgG of all samples was measured using an immune-turbidometric test on the AU 480 Chemistry Analyzer (Beckman Coulter). Results: The mean total IgG concentration of antemortem blood samples from all 100 donors was 8.9 g/L ± 3.7 g/L (median 8.9 g/L, range 1.5 to 23.8 g/L). In 80 donors the IgG concentration in the antemortem blood sample was within the normal range with values ≥6 g/L (mean 10.0 g/L ± 3.3 g/L, median 9.3 g/L,). The total IgG concentration of the postmortem blood samples was lower with 7.2 g/L ± 3.2 g/L (median 6.7 g/L, range 0.6 to 18.2 g/L). The difference between the values of the antemortem and postmortem blood samples was 1.7 g/L ± 2.6 g/L (16.3%) (median 1.6 g/L, range –7.7 to 10.1 g/L). In 36 donors this difference was less than 10%, in 23 it was between 10 and 25%, in 33 between 26 and 50%, and in 8 over 50%. In 57 donors the total IgG in the postmortem blood sample was within the normal range with ≥6 g/L, in 53 of them also the value of the antemortem blood sample was within the normal range. No correlation for total IgG was found regarding the donor characteristics (age, sex, disease) and the sample characteristics (hemolysis, postmortem time). Conclusion: Total IgG values in antemortem samples were below the lower limit of 6 g/L in 20% of the cases. Total IgG was significantly lower in the postmortem samples compared to the antemortem samples, while 57% were still above the lower limit. No correlation with the postmortem time could be found. This lowered IgG levels should be payed attention to when using postmortem blood for infectious serology testing. Additional NAT testing should be considered.

Objective Increasingly, cornea banks are recovering donor tissue from pseudophakic donors. Little is known about their suitability for Descemet membrane endothelial keratoplasty (DMEK) surgery in terms of endothelial cell density (ECD) and preparation failure. Methods and Analysis We explored ECD during donor tissue preparation in 2076 grafts. Preparation failure was analysed in 1028 grafts used in DMEK surgery at our clinic. To monitor ECD and functional results, we matched 86 DMEK patients who received pseudophakic donor grafts with similar recipients of phakic donor grafts and followed them up for 36 months. Results At recovery, mean ECD in pseudophakic donor grafts was 2193 cells/mm2 (SD 28.7) and 2364 cells/mm2 (SD 15.7) in phakic donor grafts (p<0.001). After cultivation, the difference increased as pseudophakic donor grafts lost 14% of ECD while phakic lost only 6% (p<0.001). At transplantation, mean ECD in pseudophakic donor grafts was 2272 cells/mm2 (SD 250) and 2370 cells/mm2 (SD 204) in phakic donor grafts (p<0.001). After transplantation, the difference in ECD increased as pseudophakic donor grafts lost 27.7% of ECD while phakic donor grafts lost only 13.3% (p<0.001). The risk of preparation failure in pseudophakic donor grafts was higher than in phakic donor grafts (OR 4.75, 95% CI 1.78 to 12.67, p=0.02). Visual acuity increased in both groups similarly. Conclusions Pseudophakic donor grafts have a lower ECD, are more prone to endothelial cell loss during recovery and surgery and are associated with a higher risk of preparation failure. Cornea banks and surgeons should consider this in the planning of graft preparation and transplantation.

Spinocerebellar ataxia type 14 (SCA-PRKCG, formerly SCA14) is a rare, slowly progressive disorder caused by conventional mutations in protein kinase Cγ (PKCγ). The disease usually manifests with ataxia, but previous reports suggested PRKCG variants in retinal pathology. To systematically investigate for the first time visual function and retinal morphology in patients with SCA-PRKCG. Seventeen patients with PRKCG variants and 17 healthy controls were prospectively recruited, of which 12 genetically confirmed SCA-PRKCG patients and 14 matched controls were analyzed. We enquired a structured history for visual symptoms. Vision-related quality of life was obtained with the National Eye Institute Visual Function Questionnaire (NEI-VFQ) including the Neuro-Ophthalmic Supplement (NOS). Participants underwent testing of visual acuity, contrast sensitivity, visual fields, and retinal morphology with optical coherence tomography (OCT). Measurements of the SCA-PRKCG group were analyzed for their association with clinical parameters (ataxia rating and disease duration). SCA-PRKCG patients rate their vision-related quality of life in NEI-VFQ significantly worse than controls. Furthermore, binocular visual acuity and contrast sensitivity were worse in SCA-PRKCG patients compared with controls. Despite this, none of the OCT measurements differed between groups. NEI-VFQ and NOS composite scores were related to ataxia severity. Additionally, we describe one patient with a genetic variant of uncertain significance in the catalytic domain of PKCγ who, unlike all confirmed SCA-PRKCG, presented with a clinically silent epitheliopathy. SCA-PRKCG patients had reduced binocular vision and vision-related quality of life. Since no structural retinal damage was found, the pathomechanism of these findings remains unclear.

Within the framework of obtaining a valid authorization for tissue preparation of cryopreserved human amniotic membranes at the Paul Ehrlich Institute, pursuant to 21a paragraph 1 of the German Medicines Act (AMG), parts of the existing good practice procedures for acquisition of cryopreserved human amniotic membranes from donor placentas were reviewed and supplemented by new knowledge. The present good practice procedures were formulated in cooperation with members of the section for tissue transplantation and biotechnology of the German Ophthalmological Society. The current revised version is presented in this article.

Purpose: To investigate functional and anatomical results up to 12months after Descemet's membrane endothelial keratoplasty (DMEK) for Fuchs' endothelial dystrophy (FED) versus bullous keratopathy (BK) in consideration of morphologic characteristics on host's endothelium-Descemet's membranes (EDM).Methods: In a prospective consecutive case series, 119 eyes underwent a primary DMEK for FED or BK. Intraoperatively obtained EDM were investigated immunohistologically. Clinical and morphological parameters were compared between FED and BK.Results: Overall, the 12-months best-corrected visual acuity (BCVA) was 0.14 logMAR, and 0.10 logMAR in eyes without vision-limiting comorbidities; thereby no differences were revealed between eyes with FED and BK up to 12months postoperative (p=0.186 and p=0.095, respectively). Correspondingly, the mean central corneal thickness (CCT) measured 520 vs. 529 mu m and the mean endothelial cell density (ECD) was 1743 vs. 1457 cells/mm(2) for FED and BK, 12months postoperative. Regarding CCT and ECD, no differences were observed between the groups (p=0.181 and p=0.112, respectively). The overall detachment rate was 40% (48/119). Comparing FED and BK the detachment rates did not differ, which were 41% vs. 39% and 43% vs. 35%, in pseudophakic eyes (p=0.554 and p=0.601, respectively). Yet, the distribution of recurring graft detachments differed between FED and BK; secondary re-detachments were more frequent in the FED group (7 cases). Regarding histologic investigations, a lower ECD was found in specimens with BK, no differences were revealed for EDM and anterior banded layer thicknesses. Immunohistologically, differences in the distribution of fibronectin and cytokeratin were observed. A rarification of matrix proteins was found in EDM complexes with FED.Conclusions: DMEK produces similar results for FED and BK. However, the postoperative course may differ with regard to the recurrence of secondary graft detachments that may be associated by histopathologic particularities.

The processing of tissues and cells for transplant bears a risk of microbial contamination which might cause an infection in the recipient. Tissues and cells are therefore treated with antibiotics to reduce the amount of microorganisms. Microbiological controls have to be simple, fast and sensitive and need to be performed according to the specifications of the European Pharmacopoeia. The presented article describes pragmatic approaches for the validation of such specimens with a residual activity of antibiotics inhibiting microbial growth and with that complicating the interpretation of the results.

ZusammenfassungBei der Verarbeitung von Gewebe und Zellen zur Anwendung am Patienten können mikrobiologische Kontaminationen auftreten, die bei den Empfängern Infektionen verursachen können. Zur Keimreduktion werden Gewebe und Zellen daher mit Antibiotika behandelt. Die mikrobiologischen Kontrollmethoden müssen einfach, schnell und sensitiv sein und gemäß den Vorschriften im Europäischen Arzneibuch durchgeführt werden. Der vorliegende Beitrag beschreibt pragmatische Lösungsansätze für die Validierung von Proben, bei welchen die Restaktivität von Antibiotika das Keimwachstum hemmt und die Interpretation der Testergebnisse erschwert.

Background/Purpose: Toxic maculopathy is a rare but severe complication of chloroquine intake. Although the phenotype of established maculopathy was analyzed in detail, few data exist on the ophthalmologic findings in the early stage. Methods: The authors present 4 female patients with unequivocal signs of chloroquine maculopathy (bilateral [peri-]central scotoma in the visual fields, structural alterations of the macula in the optical coherence tomography) but normal or atypical findings as to fundus autofluorescence imaging. Results: In all patients, optical coherence tomography showed perifoveal thinning and subtle alterations of the outer retinal layers. In one patient, the latter was limited to the pericentral region, whereas it showed a more diffuse distribution in two other patients. One patient showed a combination of pericentral and diffuse damage. Multifocal electroretinography was recorded in three patients and revealed the typical (peri-)central amplitude reductions. Conclusion: A normal fundus autofluorescence does not rule out toxic maculopathy. Optical coherence tomography and multifocal electroretinography seem to be more sensitive in the early stage of the disease. In case of typical complaints and visual fields, the optical coherence tomography has to be evaluated for subtle alterations of the outer retina. Their presence justifies the cessation of the drug. Multifocal electroretinography may be of special value in these problematic cases.

ObjectiveThis validation study investigates the treatment of cornea organ culture medium (Modified Eagle Medium, Biochrom GmbH, Berlin, Germany) with RESEP, a new medical device for antibiotics removal, before microbiological testing with BACTECTMblood culture bottles.Methods and analysis10–100 colony forming units ofStaphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, Bacillus subtillis, Aspergillus brasiliensis, Clostridium sporogenes, Enterobacter cloacaeandStaphylococcus epidermidiswere inoculated in 9mL of cornea organ culture medium. In group A, the medium was withdrawn with RESEP and treated for 20 min at room temperature, and then inoculated in BACTEC Plus Aerobic/F/Anaerobic/F blood culture bottles. In group B, the medium, spiked by the inoculation of microorganism, was injected directly. For each strain, a growth control was performed, by direct inoculation of the microorganisms in BACTECTMvials (positive control). All samples were incubated in the automated BACTECTMblood culture system at 36°C ±1°C for maximum of 14 days or until a positive reading. The elimination of antibiotics from the medium by RESEP was determined by high-performance liqiud chromatography.ResultsAfter 20 min of RESEP treatment, 100% (n=9) of streptomycin, 100% (n=9) of amphotericin B and 99.7% (n=9) of penicillin G were eliminated. In group A , all microorganisms were detected within 3 days of incubation with a sensitivity of 100% (n=99) and showed no significant delay compared with the positive controls. In group B, the overall sensitivity was 67.9% (n=96) with a significant delay until detection of microbial growth for all tested microorganisms except forA. brasiliensis.ConlclusionThe use of RESEP to eliminate the antibiotics from cornea organ culture medium increases the sensitivity of the microbiological testing with BACTECTMPlus blood culture bottles significantly and fulfils the requirements of the European Pharmacopoeia method suitability test.

Program Number: 5264 Poster Board Number: B0217 Presentation Time: 8:30 AM–10:15 AM Quality of Vision After Femtosecond Laser or Mechanical Keratome for Laser In Situ Keratomileusis: A Prospective Randomized Contralateral Eye Study Irma Muminovic, Edward E. Manche. Ophthalmology, Stanford University, Palo Alto, CA. Purpose: To compare the effect of femtosecond laser or mechanical keratome for LASIK on subjective quality of vision. Methods: Fifty-one patients were randomized to receive femtosecond laser for LASIK for one eye and mechanical keratome for LASIK for the fellow eye. Study participants completed a questioner assessing quality of vision and visual symptoms (daytime and nighttime glare, nighttime and daytime clarity, halos, haze, dry eye, severe dry eye, grittiness, fluctuating vision, and double vision) at postoperative months 1, 3, 6, and 12. Results: At 1,3,6, and 12 months postoperatively, there was no significant difference in any individual symptoms between the femtosecond laser and mechanical keratome group. When comparing their vision before and after LASIK at postoperative month 12, 84.4% patients reported better vision after LASIK in the eye treated with mechanical keratome, whereas 80% patients reported better vision after LASIK in the eye treated with femtosecond laser (P=0.3901). Seven percent of patients reported worse dry dye symptoms in the eye treated with mechanical keratome compared to before LASIK while 9% of patient reported worse dry eye symptoms in the eye treated with femtosecond laser compared to before LASIK (P=0.3489). When comparing fluctuation in vision, 9% of patient reported more fluctuation of vision in the eye treated with mechanical keratome while 13% of patients reported more fluctuation of vision in the eye treated with femtosecond laser (P=0.2540). Conclusions: At 12 months after surgery, there were no significant difference between reported quality of vision between femtosecond laser and mechanical keratome for LASIK. Commercial Relationships: Irma Muminovic, None; Edward E. Manche, Calhoun Vision, Inc. (I), Allergan, Inc. (C), Veralas, Inc. (I), Seros Medical, LLC. (P), Carl Zeiss Meditec, Inc. (C), Abbott Medical Optics, Inc. (C), Avellino Laboratoires, Inc. (C), Seros Medical, LLC (I), Guidepoint Global (C)

PURPOSE: To explore the impact of intracameral air tamponade pressure and duration on graft attachment and rebubbling rates.DESIGN: A prospective, interventional, nonrandomized study.METHODS: SETTING: Department of Ophthalmology, Charite - Universitatsmedizin Berlin. STUDY POPULATION: One hundred seventeen patients who underwent Descemet membrane endothelial keratoplasty (DMEK). OBSERVATION: Intraocular pressure (IOP) at the end of the surgery, immediately after filling the anterior chamber with air, categorized into low (< 10 mm Hg), normal (10-20 mm Hg), and high (> 20 mm Hg), and the time until partial removal of the air. MAIN OUTCOME MEASURES: Rebubbling rates and endothelial cell density over a 3-month follow-up period analyzed by a multivariable Cox regression model and an analysis of covariance model.RESULTS: Thirty-two patients required a rebubbling (27% [95% CI 19%-35%]). Nine patients required more than 1 rebubbling (7% [95% CI 3%-12%]). Compared with normal IOP, lower (HR 8.98 [95% CI 1.07-75.41]) and higher IOP (HR 10.63 [95% CI 1.44-78.27]) increased the risk of requiring a rebubbling (P = .006). Independent of the IOP, an air tamponade duration beyond 2 hours reduced the risk of rebubbling (HR 0.36 [95% CI 0.18-0.71, P = .003]). One month after surgery, the mean endothelial cell loss was 13% (95% CI 2%-25%) and 23% (95% CI 17%-29%) in the group with air tamponade duration of below and above 2 hours, respectively (P = .126). At 3 months after surgery, it was 31% (95% CI 17%-42%) and 42% (95% CI 32%-52%) in the respective groups (P = .229).CONCLUSIONS: A postsurgical air tamponade of at least 2 hours with an IOP within the physiological range could help to reduce rebubbling rates. (C) 2017 Elsevier Inc. All rights reserved.