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

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 (R) VIEW) under an 18mm sBCL (OmniLenz (R)). 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.