To assess the safety, efficacy, patients’ satisfaction and acceptability of Rexon-Eye electrotherapy in treating Asian severe dry eye disease (DED) patients.
Prospective parallel-arm pilot study recruiting 40 DED Chinese patients with >moderate recalcitrant DED (Contact Lens Research Unit [CCLRU] > grade 2). Subjects were randomized into 2 groups, undergoing four weekly treatment sessions each: group 1 received full treatment power; group 2 received control treatment (power 1 treatment). Non-invasive tear break-up time (NIBUT), cornea fluorescein staining graded via CCLRU and Schirmer’s I test were compared pre- and 2 months post-treatment. The SPEED and QUEST questionnaires that evaluated subjective symptoms and treatment satisfaction, respectively, at baseline and 2 weeks post-treatment were carried out. Tear cytokine levels in both groups were examined at 2 weeks post-treatment.
The amount of improvement in post-treatment corneal staining in the inferior corneal zone was significant in Group 1 (
In Asian DED patients treated with Rexon-Eye, inferior cornea staining showed significant improvement compared to placebo, and eyes with greater cornea staining at baseline achieved a greater improvement in staining. There were no other significant improvements in NIBUT and Schirmer’s 1. Rexon-Eye also improved subjective DED scores in 41.7% of eyes without any adverse effects.