Travé-Huarte, Sònia and Wolffsohn, James S. (2024). Sutureless Dehydrated Amniotic Membrane (Omnigen) Application Using a Specialised Bandage Contact Lens (OmniLenz) for the Treatment of Dry Eye Disease:A 6-Month Randomised Control Trial. Medicina, 60 (6),
Abstract
Background and Objectives: Dry Eye Disease (DED) is a chronic condition characterised by tear film instability and ocular surface disruption, significantly impacting patients' quality of life. This study aimed to provide top-level clinical evidence for the long-term efficacy of dehydrated amniotic membrane (dAM, Omnigen®) delivered via a specialised bandage contact lens (sBCL, OmniLenz) for managing moderate-to-severe DED. Materials and Methods: This randomised controlled trial (NCT04553432) involved 93 participants with moderate-to-severe DED, randomised to receive a 1-week bilateral treatment of either dAM (17 mm diameter with 6 mm central 'window') applied under a sBCL or sBCL alone. Participants were assessed at baseline and followed up at 1, 3, and 6 months post-treatment. Outcomes included changes in symptomatology, tear film and ocular surface measurements, and in vivo confocal microscopy imaging of corneal nerve parameters and corneal dendritic cell (CDC) counts. Results: The dAM-sBCL group demonstrated a 65% reduction in OSDI scores at 6 months (p < 0.001), with 88% of participants showing improvement at 1 month. Corneal staining was significantly reduced in both groups. dAM-sBCL provided significant improvements in corneal nerve parameters at 1 month, with sustained positive trends at 3 months. Additionally, dAM-sBCL significantly reduced mature CDC counts, suggesting an anti-inflammatory effect. Conclusions: Treatment with dAM-sBCL for just 1 week significantly and rapidly improved dry eye symptoms as well as ocular surface signs for at least 3 months. It also enhanced corneal nerve health while reducing activated/mature corneal inflammatory cell numbers, presenting a safe and promising new treatment for moderate-to-severe DED.
Publication DOI: | https://doi.org/10.3390/medicina60060985 |
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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 research was an Investigator Initiated Study funded by NuVision and the Na- tional Institute for Health Research (NIHR) Birmingham Biomedical Research Centre https://www. birminghambrc.nihr.ac.uk/ |
Additional Information: | © 2024 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https:// creativecommons.org/licenses/by/ 4.0/) |
Uncontrolled Keywords: | dry eye disease,dehydrated amniotic membrane,randomised controlled trial,ocular surface disease index,corneal nerve regeneration,Cornea,Amnion/transplantation,Bandages,Humans,Middle Aged,Male,Treatment Outcome,Dry Eye Syndromes/therapy,Contact Lenses,Quality of Life,Female,Adult,Aged,General Medicine |
Publication ISSN: | 1648-9144 |
Data Access Statement: | Data is unavailable due to privacy restrictions. |
Last Modified: | 08 Nov 2024 18:45 |
Date Deposited: | 27 Jun 2024 13:30 |
Full Text Link: | |
Related URLs: |
https://www.mdp ... 8-9144/60/6/985
(Publisher URL) http://www.scop ... tnerID=8YFLogxK (Scopus URL) |
PURE Output Type: | Article |
Published Date: | 2024-06-15 |
Published Online Date: | 2024-06-15 |
Accepted Date: | 2024-06-12 |
Authors: |
Travé-Huarte, Sònia
(
0000-0001-5604-0042)
Wolffsohn, James S. ( 0000-0003-4673-8927) |