RESUMEN
PURPOSE: To investigate the effects of a single instillation of hypotonic 0.18% sodium hyaluronate artificial tears on wavefront aberrations in dry eye patients. METHODS: Fifty patients with dry eye were recruited into this single-center, prospective, double-masked, randomized controlled trial. Patients were randomly assigned to receive one drop of preservative-free, hypotonic 0.18% sodium hyaluronate (treatment) in one eye and one drop of sterile 0.9% sodium chloride solution (control) in the other eye. Ocular aberrations evaluated by a Hartmann-Shack aberrometer and severity of dry eye symptoms graded by a questionnaire (at baseline, 1, 10, 30, 60, and 120 minutes after instillation) were the main outcome measures. RESULTS: After a single instillation of one drop of the allocated eye drops, there were no statistically significant differences between the treatment and control groups in total higher-order aberrations, coma, and spherical aberrations during the study period (p = 0.40, 0.57, and 0.16, respectively). Although a statistically significant (p = 0.04) decrease from baseline in spherical aberrations was noted in the treatment group at 1 minute following instillation, it gradually increased back to baseline values at later time points. A statistically significant diminishment of dry eye symptoms compared with the placebo was reported at all time points by the treatment group (p < 0.001). CONCLUSIONS: A single instillation of hypotonic 0.18% sodium hyaluronate eye drops is safe and effective in alleviating subjective dry eye symptoms; however, it does not appear to affect higher-order aberrations in moderate to severe dry eye patients.