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

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.

Keywords:

• dry eye disease
• amniotic membrane
• bandage contact lens

Disclosure

This study was an investigator-initiated study, funded by NuVision^® Biotherapies Ltd, UK. The dAM (Omnigen^®) and bandage contact lenses (OmniLenz^®) were provided by NuVision^® Biotherapies as part of the study. NuVision^® Biotherapies were not involved in the study design, collection, analysis, and interpretation of data, or presentation of the results. ST-H has received consultancy from Alcon, Santen and Thea in the past, she is deputy academic chair and fellowship lead of the British Contact Lens Association. JSW has funding from 3M, Alcon, Allergan, CooperVision, Johnson and Johnson Vision, Rayner, M2C Pharmaceuticals, Menicon, Novartis, Scope Ophthalmic, SightGlass, Thea and the Eye Doctor; he is a consultant to AOS, Bausch and Lomb, Alcon, CooperVision. CSIDryEye, DopaVisin, Medmont, Novartis, NuVision^®, Santen, Scope Ophthalmic, SightGlass, Thea and TRB Chemedica International; he is academic chair of the British Contact Lens Association, chief scientific officer of the International Myopia Institute and on the executive of the Tear Film and Ocular Surface Society; he is a founder and has stock ownership in Aston Vision Sciences, Eyoto and Wolffsohn Research Ltd. The authors report no other conflicts of interest in this work.