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Clinical Characterization of Suprachoroidal Injection Procedure Utilizing a Microinjector across Three Retinal Disorders

PURPOSE: This study assessed physician-investigator experience with suprachoroidal (SC) injections, an investigational therapeutic administration technique using a 900 or 1100 µm microneedle to inject drugs into the SC space. METHODS: Datasets from six clinical trials across three diseases (noninfec...

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Autores principales: Wan, Chen-rei, Kapik, Barry, Wykoff, Charles C., Henry, Christopher R., Barakat, Mark R., Shah, Milan, Andino, Rafael V., Ciulla, Thomas A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Association for Research in Vision and Ophthalmology 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7585395/
https://www.ncbi.nlm.nih.gov/pubmed/33150052
http://dx.doi.org/10.1167/tvst.9.11.27
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author Wan, Chen-rei
Kapik, Barry
Wykoff, Charles C.
Henry, Christopher R.
Barakat, Mark R.
Shah, Milan
Andino, Rafael V.
Ciulla, Thomas A.
author_facet Wan, Chen-rei
Kapik, Barry
Wykoff, Charles C.
Henry, Christopher R.
Barakat, Mark R.
Shah, Milan
Andino, Rafael V.
Ciulla, Thomas A.
author_sort Wan, Chen-rei
collection PubMed
description PURPOSE: This study assessed physician-investigator experience with suprachoroidal (SC) injections, an investigational therapeutic administration technique using a 900 or 1100 µm microneedle to inject drugs into the SC space. METHODS: Datasets from six clinical trials across three diseases (noninfectious uveitis; diabetic macula edema, and retinal vein occlusion) were assessed. In addition to a user survey, retrospective correlations were performed between procedural variables (needle length), and demographics, and ocular characteristics. RESULTS: In the user survey, 84% (31/37) of physician-investigators did not perceive the SC injections to be meaningfully more challenging than other ocular injections. For the correlation analysis, the 900 µm needle was used for 71% (412/581) of baseline injections, and switching to the longer needle occured in the remaining 29% of baseline injections. No statistical correlations were found between needle lengths and age, race, disorder, refraction, visual acuity, intraocular pressure, retinal central subfield thickness, or lens status. Patient gender and needle length were statistically associated, with 76% (210/275) versus 66% (202/306) of injections administered with 900 µm needles for female and male gender, respectively. Injection quadrant correlated to needle length with 78% (214/275) of superotemporal quadrant injections administered with 900 µm needles, compared with 65% (73/113) of inferotemporal quadrant injections. CONCLUSIONS: Both the user survey and the correlation analysis demonstrated that SC injection is well accepted by physician-investigators, and the two needle lengths accommodate a wide range of anatomic and demographic variables. TRANSLATIONAL RELEVANCE: These results, along with the presented ex-vivo endoscopic imaging, suggest that SC injection could be readily adopted in clinical practice for targeted compartmentalized delivery of ocular therapeutics.
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spelling pubmed-75853952020-11-03 Clinical Characterization of Suprachoroidal Injection Procedure Utilizing a Microinjector across Three Retinal Disorders Wan, Chen-rei Kapik, Barry Wykoff, Charles C. Henry, Christopher R. Barakat, Mark R. Shah, Milan Andino, Rafael V. Ciulla, Thomas A. Transl Vis Sci Technol Article PURPOSE: This study assessed physician-investigator experience with suprachoroidal (SC) injections, an investigational therapeutic administration technique using a 900 or 1100 µm microneedle to inject drugs into the SC space. METHODS: Datasets from six clinical trials across three diseases (noninfectious uveitis; diabetic macula edema, and retinal vein occlusion) were assessed. In addition to a user survey, retrospective correlations were performed between procedural variables (needle length), and demographics, and ocular characteristics. RESULTS: In the user survey, 84% (31/37) of physician-investigators did not perceive the SC injections to be meaningfully more challenging than other ocular injections. For the correlation analysis, the 900 µm needle was used for 71% (412/581) of baseline injections, and switching to the longer needle occured in the remaining 29% of baseline injections. No statistical correlations were found between needle lengths and age, race, disorder, refraction, visual acuity, intraocular pressure, retinal central subfield thickness, or lens status. Patient gender and needle length were statistically associated, with 76% (210/275) versus 66% (202/306) of injections administered with 900 µm needles for female and male gender, respectively. Injection quadrant correlated to needle length with 78% (214/275) of superotemporal quadrant injections administered with 900 µm needles, compared with 65% (73/113) of inferotemporal quadrant injections. CONCLUSIONS: Both the user survey and the correlation analysis demonstrated that SC injection is well accepted by physician-investigators, and the two needle lengths accommodate a wide range of anatomic and demographic variables. TRANSLATIONAL RELEVANCE: These results, along with the presented ex-vivo endoscopic imaging, suggest that SC injection could be readily adopted in clinical practice for targeted compartmentalized delivery of ocular therapeutics. The Association for Research in Vision and Ophthalmology 2020-10-22 /pmc/articles/PMC7585395/ /pubmed/33150052 http://dx.doi.org/10.1167/tvst.9.11.27 Text en Copyright 2020 The Authors http://creativecommons.org/licenses/by-nc-nd/4.0/ This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
spellingShingle Article
Wan, Chen-rei
Kapik, Barry
Wykoff, Charles C.
Henry, Christopher R.
Barakat, Mark R.
Shah, Milan
Andino, Rafael V.
Ciulla, Thomas A.
Clinical Characterization of Suprachoroidal Injection Procedure Utilizing a Microinjector across Three Retinal Disorders
title Clinical Characterization of Suprachoroidal Injection Procedure Utilizing a Microinjector across Three Retinal Disorders
title_full Clinical Characterization of Suprachoroidal Injection Procedure Utilizing a Microinjector across Three Retinal Disorders
title_fullStr Clinical Characterization of Suprachoroidal Injection Procedure Utilizing a Microinjector across Three Retinal Disorders
title_full_unstemmed Clinical Characterization of Suprachoroidal Injection Procedure Utilizing a Microinjector across Three Retinal Disorders
title_short Clinical Characterization of Suprachoroidal Injection Procedure Utilizing a Microinjector across Three Retinal Disorders
title_sort clinical characterization of suprachoroidal injection procedure utilizing a microinjector across three retinal disorders
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7585395/
https://www.ncbi.nlm.nih.gov/pubmed/33150052
http://dx.doi.org/10.1167/tvst.9.11.27
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