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Allogeneic and autologous serum eye drops: a pilot double‐blind randomized crossover trial

PURPOSE: Serum eye drops (SEDs) are used to treat a variety of ocular surface defects. Serum eye drops (SEDs) are normally produced from the patient’s blood. However, not all patients can donate sufficient or suitable blood, and logistics can be challenging. Allogeneic blood from voluntary blood don...

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Autores principales: van der Meer, Pieter F., Verbakel, Sanne K., Honohan, Áine, Lorinser, Jos, Thurlings, Rogier M., Jacobs, Joannes F.M., de Korte, Dirk, Eggink, Catharina A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9544559/
https://www.ncbi.nlm.nih.gov/pubmed/33590715
http://dx.doi.org/10.1111/aos.14788
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author van der Meer, Pieter F.
Verbakel, Sanne K.
Honohan, Áine
Lorinser, Jos
Thurlings, Rogier M.
Jacobs, Joannes F.M.
de Korte, Dirk
Eggink, Catharina A.
author_facet van der Meer, Pieter F.
Verbakel, Sanne K.
Honohan, Áine
Lorinser, Jos
Thurlings, Rogier M.
Jacobs, Joannes F.M.
de Korte, Dirk
Eggink, Catharina A.
author_sort van der Meer, Pieter F.
collection PubMed
description PURPOSE: Serum eye drops (SEDs) are used to treat a variety of ocular surface defects. Serum eye drops (SEDs) are normally produced from the patient’s blood. However, not all patients can donate sufficient or suitable blood, and logistics can be challenging. Allogeneic blood from voluntary blood donors does not have these disadvantages. Our aim was to evaluate whether autologous and allogeneic SEDs have comparable efficacy and tolerability. METHODS: In a prospective, double‐blind crossover trial, patients with severe dry eyes were randomized to first receive autologous SEDs for one month, followed by one‐month washout, before receiving allogeneic SEDs for 1 month; or receive the SED preparations in reverse order. The Ocular Surface Disease Index (OSDI) was the primary endpoint, and various secondary endpoints were determined. A linear mixed model with random intercept for each patient was applied per treatment group to compare the pre‐ and postoutcome measurements. RESULTS: Nineteen patients were enrolled, of whom 15 completed the trial. When autologous SEDs were used, the mean ± SD OSDI improved from 62 ± 19 to 57 ± 18. For allogeneic SEDs, the OSDI changed from 59 ± 20 to 56 ± 23. The estimated mean difference (95% confidence interval) was −4.2 (−9.5 to 1.2) for autologous and −4.5 (−9.8 to 0.9) for allogeneic SEDs (both, not significant). Adverse events were mild and resolved completely. CONCLUSION: Autologous and allogeneic SEDs have comparable efficacy and tolerability for use in patients with severe dry eyes. Allogeneic SEDs are therefore an attractive alternative for patients who need SEDs but are clinically or logistically unable to donate blood.
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spelling pubmed-95445592022-10-14 Allogeneic and autologous serum eye drops: a pilot double‐blind randomized crossover trial van der Meer, Pieter F. Verbakel, Sanne K. Honohan, Áine Lorinser, Jos Thurlings, Rogier M. Jacobs, Joannes F.M. de Korte, Dirk Eggink, Catharina A. Acta Ophthalmol Original Articles PURPOSE: Serum eye drops (SEDs) are used to treat a variety of ocular surface defects. Serum eye drops (SEDs) are normally produced from the patient’s blood. However, not all patients can donate sufficient or suitable blood, and logistics can be challenging. Allogeneic blood from voluntary blood donors does not have these disadvantages. Our aim was to evaluate whether autologous and allogeneic SEDs have comparable efficacy and tolerability. METHODS: In a prospective, double‐blind crossover trial, patients with severe dry eyes were randomized to first receive autologous SEDs for one month, followed by one‐month washout, before receiving allogeneic SEDs for 1 month; or receive the SED preparations in reverse order. The Ocular Surface Disease Index (OSDI) was the primary endpoint, and various secondary endpoints were determined. A linear mixed model with random intercept for each patient was applied per treatment group to compare the pre‐ and postoutcome measurements. RESULTS: Nineteen patients were enrolled, of whom 15 completed the trial. When autologous SEDs were used, the mean ± SD OSDI improved from 62 ± 19 to 57 ± 18. For allogeneic SEDs, the OSDI changed from 59 ± 20 to 56 ± 23. The estimated mean difference (95% confidence interval) was −4.2 (−9.5 to 1.2) for autologous and −4.5 (−9.8 to 0.9) for allogeneic SEDs (both, not significant). Adverse events were mild and resolved completely. CONCLUSION: Autologous and allogeneic SEDs have comparable efficacy and tolerability for use in patients with severe dry eyes. Allogeneic SEDs are therefore an attractive alternative for patients who need SEDs but are clinically or logistically unable to donate blood. John Wiley and Sons Inc. 2021-02-15 2021-12 /pmc/articles/PMC9544559/ /pubmed/33590715 http://dx.doi.org/10.1111/aos.14788 Text en © 2021 The Authors. Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Original Articles
van der Meer, Pieter F.
Verbakel, Sanne K.
Honohan, Áine
Lorinser, Jos
Thurlings, Rogier M.
Jacobs, Joannes F.M.
de Korte, Dirk
Eggink, Catharina A.
Allogeneic and autologous serum eye drops: a pilot double‐blind randomized crossover trial
title Allogeneic and autologous serum eye drops: a pilot double‐blind randomized crossover trial
title_full Allogeneic and autologous serum eye drops: a pilot double‐blind randomized crossover trial
title_fullStr Allogeneic and autologous serum eye drops: a pilot double‐blind randomized crossover trial
title_full_unstemmed Allogeneic and autologous serum eye drops: a pilot double‐blind randomized crossover trial
title_short Allogeneic and autologous serum eye drops: a pilot double‐blind randomized crossover trial
title_sort allogeneic and autologous serum eye drops: a pilot double‐blind randomized crossover trial
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9544559/
https://www.ncbi.nlm.nih.gov/pubmed/33590715
http://dx.doi.org/10.1111/aos.14788
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