The Effect of Autologous Serum Tears 50% on the Ocular Surface of Patients With Severe Dry Eye Disease due to Sjogren Syndrome: A Prospective, Double-Blind, Randomized, Controlled, Contralateral Eye Study.

PURPOSE: To assess the impact of autologous serum (AS) tears at a 50% concentration on the ocular surface of patients with refractory dry eye disease (DED) because of Sjogren syndrome. METHODS: Twenty eyes of ten patients with severe immune-mediated DED were contralaterally randomized to receive either AS tears 50% or artificial tears between June 2021 and May 2023. Changes in tear stability, ocular surface staining, and in the morphology of the corneal sub-basal nerves were evaluated before treatment and at 1, 2, and 3 months after treatment using objective tests for DED and confocal microscopy. The microbiological safety of the used AS tears 50% was investigated using Matrix-Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry. RESULTS: The AS tears 50% group exhibited significant improvements in tear break-up time, Schirmer test scores, visual acuity, and confocal microscopy parameters of corneal nerve health at the 3-month follow-up ( P < 0.05). Corneal nerve regeneration correlated with increased tear stability and decreased ocular surface staining. Microbiological analysis identified Gram-negative bacteria in the postuse AS tears, highlighting the need for meticulous handling and storage practices. CONCLUSIONS: Treatment with AS tears at a 50% concentration markedly enhances ocular surface health, tear stability, and visual acuity, affirming the regenerative effects on corneal nerves in severe DED. The findings advocate for the therapeutic potential of higher-concentration AS tears in DED management, albeit with strict protocols to mitigate contamination risks and ensure patient safety.