P09-A130†Management of an eye bank with organ-cultured and hypothermic corneas: microbiology in endothelial grafts.

PURPOSE: To analyse the microbiologic control results taken during the processing of hypothermic and cultured corneas for endothelial transplants comparing the two groups from January to September 2022. METHODS: The microbiological controls of hypothermic corneas prepared for DSAEK or DMEK are: Transport Eusol control (pre-manipulation) and new Eusol control (post-manipulation). In cultured corneas the number of controls is increased to 4: first culture medium, evaluation culture medium, transport medium 24 hours post-evaluation and transport medium post-manipulation. RESULTS: A total of 1438 corneas were processed for transplant during the 9 months studied (321 fresh corneas and 1113 cultured corneas). A total of 557 corneas were prepared for DSAEK or DMEK, from which 89 (15,98%) were hypothermic corneas and 468 (84.O2%) were cultured. From hypothermic corneas, 65 were cut for DSAEK and with 24 corneas, pre-stripping for DMEK was done. In the case of cultured corneas, 187 were cut for DSAEK and with 281 pre-stripping for DMEK was done. The number of corneas with positive results in the microbiological controls were 15 (16,85%) in the case of fresh corneas (in 7 corneas that were prepared for DSAEK and in 8 for DMEK) and 4 cases (0,85%) in cultured corneas (in 3 corneas for DSAEK and in 1 corneas for DMEK) resulting in a clear difference between both preservation methods. Bio-surveillance notifications notified during the studied period have been a total of 5, from which 2 were SAE in hypothermic corneas and other 2 were SAE and 1 SAR, in cultured corneas, all for endothelial transplantations. CONCLUSION: The number of positive results for microorganisms was higher in the case of hypothermic corneas and the Bio-surveillance notifications were also a little bit higher in hypothermic corneas (2,25%) comparing to organ cultured corneas (0.64%). The management of an eye bank with both preservation systems is challenging with its advantages and disadvantages. The main disadvantage of hypothermic corneas is the risk of not detecting contaminations because the corneas are released without any definitive results but it is compensated by the fact that they allow us to respond to emergencies, tissue returns, apart from the economic aspect.

Lyophilized amniotic membrane graft for primary pterygium surgery: preliminary results.

The aim of this study was to investigate the tolerability, safety and efficacy of new lyophilized amniotic membrane (LAM) presentation for ocular use. A prospective case-series cohort of four patients with primary nasal pterygium which undergone excision and LAM implantation was evaluated for complications and clinical outcomes. Surgical manipulation of LAM was also assessed. LAM was stiff and easy to manipulate as well as no tearing occurred during surgery or suturing. Ocular comfort was checked and similar among those patients with LAM glued or sutured. After 12 months, there were no issues about tolerability or adverse events. Lower cosmetic outcomes (recurrence) were stated in 3 patients. Our study showed that LAM could be an effective alternative to cryopreserved amniotic membrane for graft after pterygium excision surgery. Its main advantage, storage at room temperature, can make it of immediate availability. Further studies comparing clinical outcomes of pterygium surgery with cryopreserved amniotic membrane versus LAM would confirm the benefits of the last.

Amniotic membrane extract eye drops: a new approach to severe ocular surface pathologies.

A protocol for processing amniotic membrane as an extract to be re-hydrated and administered topically as eye drops (amniotic membrane extract eye drops, AMEED) has been developed. Safety and efficacy of AMEED was assessed in patients with severe ocular surface pathologies. prospective clinical follow-up of ocular surface symptoms before and after regular application of the AMEED for at least 4 weeks on patients with severe ocular surface disorders as chronic dry eye disease, limbal stem cell deficiency, neurotrophic ulcer and permanent and disabling symptomatology that were refractory to conventional treatment. Efficacy and tolerability were assessed based on patient-reported symptoms, objective measurements, and reports of adverse events. Thirty-six eyes from 25 patients were included. Although the visual quality function score, by means of a VQF25 questionnaire, was not statistically different after the treatment (p = 0.4657), there was a clear trend, statistically significant, towards the improvement in ocular symptoms like foreign body sensation, itching and stinging (p < 0.05) and clinical presentation of the pathology. All patients with corneal ulcer showed complete epithelization. Topically applied AMEED proved to be safe, well tolerated and effective in reducing the symptoms and clinical signs of severe ocular disease. Further studies are needed to confirm the best indications for AMEED use.

30†A new step on amniotic membrane extract eye drops (AMEED) development for the treatment of severe ocular surface pathologies.

INTRODUCTION: Our tissue establishment developed a protocol for processing amniotic membranes as extracts to be re-hydrated and administered topically as eye drops, becoming a new approach to treat severe ocular surface pathologies. From 2015 to 2017 the safety and efficacy of the amniotic membrane extract eye drops (AMEED) were assessed in patients with severe ocular surface pathologies through clinical follow-up of ocular surface symptoms before and after regular application of the extract.Between 2018 and 2019 a study of 36 patients (50 eyes) treated with topical AMEED was conducted comparing 2 groups of patients: Dry Eye Disease (DED) and Wound Healing Delay (WHD) showing global similar symptomatic improvement in both groups (DED 88.9% vs WHD 100%; p= 0.486) with the WHD group especially consisting in general relief (78%) and DED group reporting more pain improvement (44%) (p=0.011). Regarding patients with autologous serum as previous treatment, no statistical differences were found in subjective or objective improvement. An overall success was achieved in 94.4% of the cases and no adverse events were found. From January 2020 to November 2021 a growth stage has been observed including more patients while optimizing and scaling the process from donation to clinical use. MATERIALS AND METHODS: We record data of placenta donation and preparation of AMEED vials from 1/1/2020 to 30/11/2021 and its clinical use including the indications for treatment, number of requesting ophthalmologists and number of patients. RESULTS: In the study period a total of 378 placentas were processed to obtain AMEDD (61 in 2020 and 317 in 2021). The number of suitable vials obtained were: 1845 and 6464 respectively and 1946 vials are stored in quarantine pending release for clinical use.A total of 9365 vials were sent for treatment of ocular surface pathologies to 31 hospitals (98% in Catalonia) and 69 requesting ophthalmologists.The total number of patients treated was 204 and the indications for treatment were 82% DED and 18% WHD. CONCLUSION: After the new product development and introduction stages, a significant increase in the use of AMEED in Catalan hospitals was observed in 2020-2021. Follow-up data of these patients should be assessed to demonstrate its efficacy and achieve the maturity stage.

38†Lyophilized amniotic membrane for pterygium surgery: long-term outcomes.

PURPOSE: To investigate the tolerability, security and long-term efficacy of lyophilized amniotic membrane (LAM) as an alternative to cryopreserved amniotic membrane in pterygium surgery. MATERIAL AND METHODS: Prospective case series of patients with primary nasal pterygium who undergone pterygium surgery and LAM implant either with sutures or glue. Postoperative follow-up was until month 24. Clinical and cosmetic outcomes, quality of life (as ocular comfort), and complications were evaluated. RESULTS: LAM was stiff and easy to manipulate as well as no tearing occurred during surgery or suturing. 4 patients (3 males) had pterygium surgery and LAM implant two with sutures and the other two with glue. Ocular comfort was checked and similar among those patients with LAM glued or sutured. After 24 months, there were no issues about tolerability or adverse events. Lower cosmetic outcomes (recurrence) were stated in 3 patients. CONCLUSION: Our study showed that LAM could be an effective alternative to cryopreserved amniotic membrane for graft after pterygium excision surgery. Its main advantage, storage at room temperature, can make it of immediate availability. Further studies comparing clinical outcomes of pterygium surgery with cryopreserved amniotic membrane versus LAM would confirm the benefits of the last.

4†New strategies in the barcelona eye bank to minimize the impact of the COVID-19 pandemic.

Since the start of the pandemic, the tissue donation in Catalonia (Spain) has decreased drastically. At the beginning of the lockdown (from March to May 2020) there was a drop of around 70% in donation of corneas and of approximately 90% in donation of placentas. Despite the fast updating of standard operating procedures, we had big difficulties in different points. For instance, in the availability of the transplant coordinator for the donor detection and evaluation, in obtaining the necessary PPE (personal protective equipment), or in the resources available in the quality control laboratories for screening. This, added to the collapse that hospitals suffered due to the large number of patients hospitalized each day, made donation levels slowly rebound.In order to provide solutions to all patients, we tried to adapt quickly to these emerging changes.In the case of corneas, we found a scenario that we had never had before. Although the cornea transplant plummeted at the beginning of the confinement (decreased by 60% compared to 2019), we run out of corneas -even for emergency situations- at the end of March.This situation led us to develop a new type of therapeutic solution in our Eye Bank. The cryopreserved cornea for tectonic purposes is a tissue that is kept frozen at -196°C and can be preserved for up to 5 years. Therefore, it is a tissue that allows us to respond to possible emergencies in subsequent similar situations.Regarding amniotic membrane for ocular care indications, the strategy was completely different. For this kind of tissue, we carried out an adaptation of our processing with two different purposes. On the one hand, to make sure that we could inactivate the SARS-CoV-2 virus, if it was there. On the other hand, to increase the donation of placentas. For this, changes in the transport medium and in the antibiotic cocktail were performed. In addition, an irradiation step was added to the final product.Little by little, it seems that the donations of corneas and placentas have been recovering. However, it is necessary to think about future contingency strategies in case a stop in donation is repeated.

Current Management of Amblyopia with New Technologies for Binocular Treatment.

Amblyopia is the most common cause of monocular poor vision affecting up to 3.7% of the global population. Classically, the first step in treatment has been optical correction, followed by patching and/or pharmacological treatment. However, this is an evolving scenario, since researchers and clinicians are interested in new binocular treatments due to the increasing development of new technologies. In this article main, current binocular treatments as Dig Rush, falling blocks, I-BiT, Occlu-tab, Vivid Vision, and movies are reviewed for binocular amblyopia management.

Global multi-site, prospective analysis of cataract surgery outcomes following ICHOM standards: the European CAT-Community.

PURPOSE: To evaluate in a large sample of patients from 10 different European centers the results of cataract surgery, characterizing the relationship between patient-reported outcomes (PROMs) and clinician-reported outcome measures (CROMs). METHODS: Prospective non-interventional multicenter observational descriptive study analyzing the clinical outcomes of a total of 3799 cases undergoing cataract surgery (mean age: 72.7 years). In all cases, the cataract surgery standard developed by the International Consortium for Health Outcomes Measurements (ICHOM) was used to register the clinical data. Three-month postoperative visual acuity and refraction data were considered CROMs, whereas Rasch-calibrated item 2 (RCCQ2) and total Catquest-9SF score (CQ) were considered PROMs. RESULTS: Postoperative corrected distance visual acuity (CDVA) was 0.3 logMAR or better in 88.7% (2505/2823) of eyes. Mean differences between preoperative and postoperative RCCQ2 and CQ scores were -3.09 and -2.39, respectively. Visual function improvement with surgery was reported by 91.5% (2163/2364) of patients. Statistically significant, although weak, correlations of postoperative CDVA with postoperative refraction, PROMs, and complications were found (0.133 ≤ r ≤0.289, p < 0.001). A predictive model (R2: 0.254) of postoperative CDVA considering 10 variables was obtained, including preoperative CDVA, different ocular comorbidities, age, gender and intraoperative complications. Likewise, another predictive model (R2: 0.148) of postoperative CQ considering a total of 14 variables was obtained, including additionally preoperative CQ, target refraction and previous surgeries. CONCLUSIONS: Cataract surgery provides an improved functional vision in most of patients although this improvement can be limited by ocular comorbidities and complications. The relationship between PROMs and CROMs is multifactorial and complex.

Amniotic membrane extract eye drops for ocular surface diseases: use and clinical outcome in real-world practice.

PURPOSE: To study the indications and clinical outcomes, in a real-word setting, of amniotic membrane extract eye drops (AMEED) use for ocular surface disease (OSD). METHODS: A retrospective study of patients treated with topical AMEED between January 2018 and January 2020 was conducted. Patients were classified in two groups according to specific OSD-dry eye disease (DED) and wound healing delay (WHD) groups. Demographics, comorbidities, treatment duration and clinical outcomes were analysed. RESULTS: A total of 50 eyes of 36 patients with or without previous treatments were included. Patients in the DED group presented more systemic comorbidities (83 vs 22%; p < 0.001) and spent more mean time under AMEED treatment (10 vs 7.2 months average) than the WHD group (p = 0.0104). In four patients, long-term treatment (more than 24 months) was reported. Global similar symptomatic improvement was reported for both groups (DED 88.9% vs WHD 100%; p = 0.486), with the WHD group especially consisting in general relief (78%) and the DED group reporting more pain improvement (44%) (p = 0.011). Regarding patients with autologous serum as a previous treatment, no statistical differences were found in subjective or objective improvement. An overall success was achieved in 94.4% of the cases and no adverse events were found. CONCLUSION: AMEED administration is a promising mean to treat OSD such as dry eye, persistent epithelial defect and corneal ulcers. Although AMEED may be effective in the treatment of severe DED and persistent epithelial defect or corneal ulcers, conclusions are limited owing to the absence of controlled clinical trials.

Corneal transplantation activity in Catalonia, Spain, from 2011 to 2018: Evolution of indications and surgical techniques.

PURPOSE: To report corneal transplant activity carried out in Catalonia (Spain) and the evolving indications for keratoplasty over an 8-year period. METHODS: Annual reports from the Catalan Transplant Organization, Spain, on corneal graft indications and techniques from 2011 to 2018 were reviewed. RESULTS: A total of 9457 keratoplasties were performed in Catalonia, from January 2011 to December 2018. The most frequent indications were bullous keratopathy (BK; 20.5%), Fuchs endothelial dystrophy (FED; 17.9%), re-graft (13.7%), and keratoconus (11.3%). Penetrating keratoplasty (PKP) accounted for 63.4% of all performed keratoplasties. Since the introduction of eye bank precut tissue for Descemet stripping automated endothelial keratoplasty (DSAEK) in 2013 and for Descemet membrane endothelial keratoplasty (DMEK) in 2017 the number of endothelial keratoplasties has drastically increased. An increasing trend of posterior lamellar techniques over the total of keratoplasties was found (p<0.001). Endothelial keratoplasties for different endothelial diseases indications (BK, FED, and re-graft), also showed and increasing trend (p<0.001). DMEK is the technique with the highest increase (statistically significantly different from linearity) over other endothelial keratoplasties in FED (p<0.001) but not in BK (p = 0.67) or re-grafts (p = 0.067). CONCLUSION: Endothelial diseases represented the top indication for keratoplasty over the 8-year period. PKP is still the most used technique in Catalonia, but endothelial keratoplasties and especially DMEK showed a significant increasing trend over the last years. This is congruent with the main rationale nowadays for keratoplasties: to customize and transplant as less tissue as possible. Therefore, the availability of precut tissue could have definitely enforced such approach.

Visual Quality and Subjective Satisfaction in Ultrathin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK) versus Descemet Membrane Endothelial Keratoplasty (DMEK): A Fellow-Eye Comparison.

BACKGROUND: To analyze objective and subjective visual quality differences between descemet membrane endothelial keratoplasty (DMEK) and ultra-thin descemet stripping automated endothelial keratoplasty (UT-DSAEK) with a paired contralateral-eye design. METHODS: A cross-sectional, comparative, and observational case series study between DMEK and UT-DSAEK were presented. Visual acuity, refractive status and corneal quality assessment were compared between both endothelial keratoplasty techniques. The sample consisted of 20 eyes (10 patients) diagnosed with Fuchs endothelial corneal dystrophy. All measurements were performed preoperatively and at six months after surgery. Analyzed data included the measurement of objective scattering index, modulation transfer function, Strehl ratio, and optical quality assessment (OQAS) values. Contrast sensitivity, subjective patient satisfaction, visual acuity, tomography, pachymetry, endothelial cell count, and refraction status were also analyzed. RESULTS: Objective and subjective visual quality variables had similar results among UT-DSAEK and DMEK procedures. Statistically significant differences favoring DMEK against UT-DSAEK were found in endothelial cell density (658.80 ± 139.33 and 1059.00 ± 421.84 cells/mm2, respectively), pachymetry (621.20 ± 33.74 and 529.70 ± 30.00 µm, respectively), and follow-up (45.50 ± 24.76 and 15.50 ± 8.43 months, respectively). CONCLUSIONS: UT-DSAEK and DMEK revealed no differences in terms of objective and subjective visual quality. However, DMEK showed a faster recovery during the follow-up, increased endothelial cell density, lower pachymetry, and a more anatomical posterior keratometry against UT-DSAEK in this case series paired-eye study.

Eye bank and theatre factors for positive microbiological culture of corneoscleral rim and cornea storage medium in the real-world.

OBJECTIVES: To evaluate microbiological culture rate and positivity of corneoscleral rim and cornea storage media as well as possible risk factors for contamination with real-world data. METHODS: Data of consecutive cornea donors implanted in the reference centre from January 2013 to January 2018 were reviewed. Information about cornea characteristics (donor demographic data, endothelial cell density, type of cornea conservation, days of storage, and precut vs full-thickness tissue), and microbiological culture information (corneoscleral rim vs storage sample, positive result) were statistically analysed. RESULTS: During the study period, 1369 corneas (737 donors) were implanted. Cultures were performed in 76.8% (n = 1052) of them and were positive in 3.2% of cases, mainly bacteria (84.4%). Corneas preserved in hypothermia represented 61.8% of all positive microbiology results (p < 0.001). Other analysed risk factors did not reach statistically significant association with microbiological positivity. None of the 34 cases with positive microbiological cultures reported ocular infection for the recipients in at least 6 months' follow-up. CONCLUSIONS: Microbiological tests rate in real-world practice are high despite not being compulsory. Organotypic cultured corneas showed a statistically less positivity in corneoscleral and storage medium than hypothermic ones, resulting in another advantage of this kind of cornea storage. Although precut corneas are thought to present less microbiological positivity, a statistically significant association was not found in the present study.

Postoperative treatment compliance rate and complications with two different protocols after pterygium excision and conjunctival autografting.

AIM: To evaluate compliance rate to pterygium postoperative treatment with two different protocols. METHODS: Review of clinical data of patients submitted to pterygium excision and conjunctival autografting in a single centre (and a single surgeon) in Barcelona between March 2014 and December 2017. Initial postoperative protocol (protocol 1) consisted of 4 months of topical steroids in a tapering fashion. Protocol 2 consisted of topical steroids tapered over 5 weeks. Compliance rate, complications and clinical outcomes were evaluated, and statistical comparisons were made. RESULTS: 120 surgeries were performed in 99 patients. Protocol 1 was applied in 63 cases and the next 57 followed protocol 2. Compliance with protocol 1 (57.6%) was lower than with protocol 2 (84.9%) (p = 0.002). Intraoperative complications (graft tear, corneal thinning, corneal perforation and bleeding) were found in 10 cases of protocol 1 and three cases of protocol 2, p = 0.08. Postoperative complications (graft dislocation, graft haematoma, ocular hypertension and recurrence) were found in 31 cases of protocol 1 (46.2%) and eight cases of protocol 2 (14%), p = 0.001. Six weeks after surgery, ocular hypertension was detected in eight cases corresponding to protocol 1 (13.6%) and two cases of protocol 2 (3.8%), p = 0.099. Recurrence rate during first year was higher in protocol 1 (26.3%) compared to protocol 2 (7.6%), p = 0.011. No cases of visual acuity worsening or infection were registered. CONCLUSION: Protocol 2 has shown to have higher compliance rate than protocol 1 and less postoperative complications, proving to be a safe and effective postoperative treatment after pterygium surgery.

Current clinical application of sclera and amniotic membrane for ocular tissue bio-replacement.

To report the current clinical applications and trends of scleral and amniotic membrane use in ophthalmology. Review of annual reports from the Catalan Transplant Organization (OCATT), on scleral patch and amniotic membrane eye indications in Catalonia region (Spain) over a 6-year period from 2013 to 2018. A total of 874 scleral and 1665 amniotic membranes patches were implanted, from January 2013 to December 2018. The most frequent indication over the 6-year period for scleral patch was glaucoma surgery (77.5%), eyelid reconstruction (5.2%) and corneal or scleral ulcer (5%). Regarding amniotic membrane, corneal ulcer (26.9%), conjunctival reconstruction (23.8%) and corneal epithelial defect (22.7%) were the most common indications. During the study period, an increasing trend was found on sclera patches for eyelid reconstruction (p = 0.0032) and amniotic membrane for inflammation management (p = 0.0198). Glaucoma surgery and corneal ulcers have represented the top indications for scleral patch and amniotic membrane use, over the period, respectively. A significant trend has also been found towards eyelid reconstruction using scleral patches and amniotic membrane for anterior segment inflammation management. This evolving scenario in tissue use for ocular surgery has to be taken into consideration, especially regarding eye banks facing current and futures changes in tissue preservation, storage and indications.

Integración de la oftalmología primaria en el ámbito hospitalario: análisis comparativo de resultados / Integration of primary care ophthalmology in the hospital: Comparative analysis of results

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