Abstract
Purpose :
The aim of the study is a single blind SEM evaluation of the effects of a multiple-acting tear substitute (Trimix®) on the microvilli of the epithelial cells of the ocular conjunctiva, in patients affected by dry eye disease (DED).
Methods :
8 subjects suffering from inflammation of the ocular surface of varying degrees were enrolled: 2 mild cases (grade 1-2 of Efron scale), 3 moderate (grade 3) and 3 with severe inflammation (grade 4). All patients were treated for 30 days BID with a multiple-action tear substitute based on 0.15% cross-linked HA, liposomes and 3% trehalose. Cytological sampling with impression procedure of the upper bulbar conjunctiva was carried out to evaluate the microvilli under SEM before (T1) and 12 hours after the end of the treatment (T2), using a specific preset scale (Del Prete et al, 2017). The results are compared with a control group (CTR) of 8 patients with the same grades of inflammation of DED groups, treated with BID balanced salt solution. Furthermore, the structure of Trimix® was identified in vitro by SEM examination.
Results :
The conjunctival smear at T2 highlighted the presence of Trimix® partially enveloping the microvilli in 7/8 patients (87.5%), with a complete restoration of the normal microvillar surface in 6/8 patients (75%) (p<0.001). In two patients of DED 3 group, affected by grade 3 and 4 an improvement in the state of the microvilli was found, showing a picture compatible with stage 1 (p<0.001). No significant changes in the microvilli were detected in CTR group (p>0.05).
Conclusions :
Microvilli are finger-like membrane protrusion, which express the vitality of the mucous and epithelial cells. Their examination allows to evaluate to what extent the drug to be tested is able to carry out a protective action or a healing role at a cellular level.The therapeutic action of Trimix® demonstrated a great epithelial trophic capacity with significant results in microvillar restoration in all subjects treated for 30 days. Furthermore its persistence on the ocular surface 12 hours after the last administration in 87.5% of cases indicates a high residence time of the product and suggests its effectiveness even in twice-daily administration.
This abstract was presented at the 2024 ARVO Imaging in the Eye Conference, held in Seattle, WA, May 4, 2024.