Travé-Huarte, Sònia and Wolffsohn, James (2024). Bilateral Sutureless Application of Human Dehydrated Amniotic Membrane with a Specialised Bandage Contact Lens for Moderate-to-Severe Dry Eye Disease: A Prospective Study with 1-Month Follow-Up. Clinical Ophthalmology, 18 , pp. 1329-1339.
Abstract
Purpose: To assess changes in symptoms and ocular surface signs following a bilateral sutureless treatment of dehydrated amniotic membrane (dAM) under a specialised bandage contact lens (sBCL) in patients with moderate-to-severe dry eye disease (DED). Patients and Methods: In this prospective pre-post interventional study, 35 patients diagnosed with moderate-to-severe DED, with an Ocular Surface Disease Index (OSDI) score >30 on current treatment, were enrolled. Assessments were conducted at baseline (day −30), after 30 days run-in with no additional treatment (day 0 – control), and 30 days post sBCL+dAM treatment (day 30 – treatment). Intervention involved two successive bilateral 4-5 day sutureless applications of dAM (17mm diameter, with a 6 mm central aperture, Omnigen® VIEW) under an 18mm sBCL (OmniLenz®). Symptomatology and ocular signs were measured using OSDI, Dry Eye Questionnaire-5 (DEQ-5), Symptom Assessment iN Dry Eye (SANDE), and other ocular surface health indicators including non-invasive breakup time, corneal and conjunctival staining, and lid wiper epitheliopathy length and width (LWE). Results: While symptomatology remained stable during the 30-day no-treatment run-in, 1-month post-dAM treatment, there was a significant reduction in OSDI scores (from 55.8 to 32.3, p<0.001), DEQ-5 (from 14.6 to 10.0, p<0.001), SANDE frequency (from 65.2 to 43.6, p<0.001), and SANDE severity (from 59.8 to 41.1, p<0.001). Additionally, there was a notable decrease in the width of LWE staining, from grade 2 (50–75% of the lid wiper) to grade 1 (25–50% of the lid wiper) (p=0.011). Conclusion: A bilateral 8–10-day treatment duration with dAM applied with sBCL demonstrated a 31 to 42% improvement in symptomatology and a decrease in ocular surface signs of mechanical stress. This innovative bilateral treatment approach offers a promising treatment modality for patients with refractory moderate-to-severe DED.
Publication DOI: | https://doi.org/10.2147/OPTH.S458715 |
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Divisions: | College of Health & Life Sciences > School of Optometry > Optometry & Vision Science Research Group (OVSRG) College of Health & Life Sciences College of Health & Life Sciences > School of Optometry > Optometry Aston University (General) |
Funding Information: | This study was an investigator-initiated study, funded by NuVision\u00AE Biotherapies Ltd, UK. The dAM (Omnigen\u00AE) and bandage contact lenses (OmniLenz\u00AE) were provided by NuVision\u00AE Biotherapies as part of the study. NuVision\u00AE Biotherapi |
Additional Information: | Copyright © 2024 Travé-Huarte and Wolffsohn. This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (https://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php |
Uncontrolled Keywords: | dry eye disease,amniotic membrane,bandage contact lens |
Publication ISSN: | 1177-5483 |
Last Modified: | 02 Dec 2024 09:06 |
Date Deposited: | 29 May 2024 12:56 |
Full Text Link: | |
Related URLs: |
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(Publisher URL) http://www.scop ... tnerID=8YFLogxK (Scopus URL) |
PURE Output Type: | Article |
Published Date: | 2024-05-13 |
Published Online Date: | 2024-05-13 |
Accepted Date: | 2024-04-28 |
Authors: |
Travé-Huarte, Sònia
Wolffsohn, James ( 0000-0003-4673-8927) |