Comparison Of Two Ophthalmic Viscoelastic Devices: Results Of A 3-Month Randomized Multicenter Trial

Published 2025 - 43rd Congress of the ESCRS

Reference: PP01.18 | Type: Free paper | DOI: 10.82333/cnq8-fb11

Authors: Ofer Daphna* ¹

¹opthalmology ,ASSUTA HASHALOM ,TEL AVIV ,Israel

Purpose

To compare two dispersive ophthalmic viscoelastic devices, Z-HYALCOAT (OVD 1) and HEALON EndoCoat (OVD 2).

Setting

Prospective randomized comparative double-masked non-inferiority trial conducted in 11 sites located in Germany (n=5), Spain (n=3), Czech Republic (n=2), and Slovakia (n=1).

Methods

Patients with clear intraocular media (excluding the presence of cataract) and scheduled for uncomplicated age-related cataract removal by phacoemulsification and intraocular lens implantation in the capsular bag were included in this trial. Both OVDs were used according to the manufacturer’s instructions for use. Study outcomes were selected based on ISO 15798:2022 and included incidence of IOP ≥ 30 mmHg (primary endpoint),

anterior chamber cell gradings

, corneal endothelial cell density (ECD), surgeon-reported device functionality, and rate of treatment-emergent adverse events (TEAEs) and device deficiencies (DDs). Follow-up timepoints included 8H, 1D, 7D, 1M and 3M following device use.

Results

In total, 242 patients were treated in this trial, 123 with OVD 1 and 119 with OVD 2. The incidence rate of patients with an IOP ≥ 30 mmHg at 8H following device use was 11.2 % in OVD 1 group and 17.0% in OVD 2 group (significant result of non-inferiority test: p=0.0005). Anterior chamber cell gradings did not differ significantly between both groups at any of the investigated time points (p≥0.2415). The ECD was also find similar between both OVDs (p≥0.6835). Surgeon-reported device functionality was generally favorable without strong preferences for either device. Finally, 9 patients (7.3%) had at least 1 TEAE affecting the study eye in OVD 1 group and 15 patients (12.6%) in OVD 2 group.

Conclusions

This trial showed that Z-HYALCOAT was non inferior to HEALON EndoCoat in terms of IOP spikes and that the two devices were highly similar in all evaluated aspects. These results suggest that both devices can be used alternatively.