Corneal Confocal Microscopy: A Biomarker for Diabetic Peripheral Neuropathy

<h3>Purpose</h3><p dir="ltr">Diagnosing early diabetic peripheral neuropathy remains a challenge due to deficiencies in currently advocated end points. The cornea is densely innervated with small sensory fibers, which are structurally and functionally comparable to intrae...

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Main Author: Ioannis N. Petropoulos (8748726) (author)
Other Authors: Georgios Ponirakis (803076) (author), Maryam Ferdousi (3301026) (author), Shazli Azmi (803074) (author), Alise Kalteniece (4373119) (author), Adnan Khan (696190) (author), Hoda Gad (6470522) (author), Bilal Bashir (17302834) (author), Andrew Marshall (719197) (author), Andrew J.M. Boulton (10891865) (author), Handrean Soran (121149) (author), Rayaz A. Malik (7372649) (author)
Published: 2021
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author Ioannis N. Petropoulos (8748726)
author2 Georgios Ponirakis (803076)
Maryam Ferdousi (3301026)
Shazli Azmi (803074)
Alise Kalteniece (4373119)
Adnan Khan (696190)
Hoda Gad (6470522)
Bilal Bashir (17302834)
Andrew Marshall (719197)
Andrew J.M. Boulton (10891865)
Handrean Soran (121149)
Rayaz A. Malik (7372649)
author2_role author
author
author
author
author
author
author
author
author
author
author
author_facet Ioannis N. Petropoulos (8748726)
Georgios Ponirakis (803076)
Maryam Ferdousi (3301026)
Shazli Azmi (803074)
Alise Kalteniece (4373119)
Adnan Khan (696190)
Hoda Gad (6470522)
Bilal Bashir (17302834)
Andrew Marshall (719197)
Andrew J.M. Boulton (10891865)
Handrean Soran (121149)
Rayaz A. Malik (7372649)
author_role author
dc.creator.none.fl_str_mv Ioannis N. Petropoulos (8748726)
Georgios Ponirakis (803076)
Maryam Ferdousi (3301026)
Shazli Azmi (803074)
Alise Kalteniece (4373119)
Adnan Khan (696190)
Hoda Gad (6470522)
Bilal Bashir (17302834)
Andrew Marshall (719197)
Andrew J.M. Boulton (10891865)
Handrean Soran (121149)
Rayaz A. Malik (7372649)
dc.date.none.fl_str_mv 2021-05-05T15:00:00Z
dc.identifier.none.fl_str_mv 10.1016/j.clinthera.2021.04.003
dc.relation.none.fl_str_mv https://figshare.com/articles/journal_contribution/Corneal_Confocal_Microscopy_A_Biomarker_for_Diabetic_Peripheral_Neuropathy/24459127
dc.rights.none.fl_str_mv CC BY 4.0
info:eu-repo/semantics/openAccess
dc.subject.none.fl_str_mv Biomedical and clinical sciences
Clinical sciences
Neurosciences
Pharmacology and pharmaceutical sciences
biomarker
clinical trials
corneal confocal microscopy
diabetic neuropathy
dc.title.none.fl_str_mv Corneal Confocal Microscopy: A Biomarker for Diabetic Peripheral Neuropathy
dc.type.none.fl_str_mv Text
Journal contribution
info:eu-repo/semantics/publishedVersion
text
contribution to journal
description <h3>Purpose</h3><p dir="ltr">Diagnosing early diabetic peripheral neuropathy remains a challenge due to deficiencies in currently advocated end points. The cornea is densely innervated with small sensory fibers, which are structurally and functionally comparable to intraepidermal nerve fibers. Corneal confocal microscopy is a method for rapid, noninvasive scanning of the living cornea with high resolution and magnification.</p><h3>Methods</h3><p dir="ltr">This narrative review presents the framework for the development of biomarkers and the literature on the use and adoption of corneal confocal microscopy as an objective, diagnostic biomarker in experimental and clinical studies of diabetic peripheral neuropathy. A search was performed on PubMed and Google Scholar based on the terms “corneal confocal microscopy,” “diabetic neuropathy,” “corneal sensitivity,” and “clinical trials.”</p><h3>Findings</h3><p dir="ltr">A substantial body of evidence underpins the thesis that corneal nerve loss predicts incident neuropathy and progresses with the severity of diabetic peripheral neuropathy. Corneal confocal microscopy also identifies early corneal nerve regeneration, strongly arguing for its inclusion as a surrogate end point in clinical trials of disease-modifying therapies.</p><h3>Implications</h3><p dir="ltr">There are sufficient diagnostic and prospective validation studies to fulfill the US Food and Drug Administration criteria for a biomarker to support the inclusion of corneal confocal microscopy as a primary end point in clinical trials of disease-modifying therapies in diabetic neuropathy.</p><h2>Other Information</h2><p dir="ltr">Published in: Clinical Therapeutics<br>License: <a href="http://creativecommons.org/licenses/by/4.0/" target="_blank">http://creativecommons.org/licenses/by/4.0/</a><br>See article on publisher's website: <a href="https://dx.doi.org/10.1016/j.clinthera.2021.04.003" target="_blank">https://dx.doi.org/10.1016/j.clinthera.2021.04.003</a></p>
eu_rights_str_mv openAccess
id Manara2_64284a9bc38fe5be4cfa6d13c7c5661a
identifier_str_mv 10.1016/j.clinthera.2021.04.003
network_acronym_str Manara2
network_name_str Manara2
oai_identifier_str oai:figshare.com:article/24459127
publishDate 2021
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rights_invalid_str_mv CC BY 4.0
spelling Corneal Confocal Microscopy: A Biomarker for Diabetic Peripheral NeuropathyIoannis N. Petropoulos (8748726)Georgios Ponirakis (803076)Maryam Ferdousi (3301026)Shazli Azmi (803074)Alise Kalteniece (4373119)Adnan Khan (696190)Hoda Gad (6470522)Bilal Bashir (17302834)Andrew Marshall (719197)Andrew J.M. Boulton (10891865)Handrean Soran (121149)Rayaz A. Malik (7372649)Biomedical and clinical sciencesClinical sciencesNeurosciencesPharmacology and pharmaceutical sciencesbiomarkerclinical trialscorneal confocal microscopydiabetic neuropathy<h3>Purpose</h3><p dir="ltr">Diagnosing early diabetic peripheral neuropathy remains a challenge due to deficiencies in currently advocated end points. The cornea is densely innervated with small sensory fibers, which are structurally and functionally comparable to intraepidermal nerve fibers. Corneal confocal microscopy is a method for rapid, noninvasive scanning of the living cornea with high resolution and magnification.</p><h3>Methods</h3><p dir="ltr">This narrative review presents the framework for the development of biomarkers and the literature on the use and adoption of corneal confocal microscopy as an objective, diagnostic biomarker in experimental and clinical studies of diabetic peripheral neuropathy. A search was performed on PubMed and Google Scholar based on the terms “corneal confocal microscopy,” “diabetic neuropathy,” “corneal sensitivity,” and “clinical trials.”</p><h3>Findings</h3><p dir="ltr">A substantial body of evidence underpins the thesis that corneal nerve loss predicts incident neuropathy and progresses with the severity of diabetic peripheral neuropathy. Corneal confocal microscopy also identifies early corneal nerve regeneration, strongly arguing for its inclusion as a surrogate end point in clinical trials of disease-modifying therapies.</p><h3>Implications</h3><p dir="ltr">There are sufficient diagnostic and prospective validation studies to fulfill the US Food and Drug Administration criteria for a biomarker to support the inclusion of corneal confocal microscopy as a primary end point in clinical trials of disease-modifying therapies in diabetic neuropathy.</p><h2>Other Information</h2><p dir="ltr">Published in: Clinical Therapeutics<br>License: <a href="http://creativecommons.org/licenses/by/4.0/" target="_blank">http://creativecommons.org/licenses/by/4.0/</a><br>See article on publisher's website: <a href="https://dx.doi.org/10.1016/j.clinthera.2021.04.003" target="_blank">https://dx.doi.org/10.1016/j.clinthera.2021.04.003</a></p>2021-05-05T15:00:00ZTextJournal contributioninfo:eu-repo/semantics/publishedVersiontextcontribution to journal10.1016/j.clinthera.2021.04.003https://figshare.com/articles/journal_contribution/Corneal_Confocal_Microscopy_A_Biomarker_for_Diabetic_Peripheral_Neuropathy/24459127CC BY 4.0info:eu-repo/semantics/openAccessoai:figshare.com:article/244591272021-05-05T15:00:00Z
spellingShingle Corneal Confocal Microscopy: A Biomarker for Diabetic Peripheral Neuropathy
Ioannis N. Petropoulos (8748726)
Biomedical and clinical sciences
Clinical sciences
Neurosciences
Pharmacology and pharmaceutical sciences
biomarker
clinical trials
corneal confocal microscopy
diabetic neuropathy
status_str publishedVersion
title Corneal Confocal Microscopy: A Biomarker for Diabetic Peripheral Neuropathy
title_full Corneal Confocal Microscopy: A Biomarker for Diabetic Peripheral Neuropathy
title_fullStr Corneal Confocal Microscopy: A Biomarker for Diabetic Peripheral Neuropathy
title_full_unstemmed Corneal Confocal Microscopy: A Biomarker for Diabetic Peripheral Neuropathy
title_short Corneal Confocal Microscopy: A Biomarker for Diabetic Peripheral Neuropathy
title_sort Corneal Confocal Microscopy: A Biomarker for Diabetic Peripheral Neuropathy
topic Biomedical and clinical sciences
Clinical sciences
Neurosciences
Pharmacology and pharmaceutical sciences
biomarker
clinical trials
corneal confocal microscopy
diabetic neuropathy