Comparison of treatment efficacy between 100% platelet-rich plasma and 100% serum eye drops in moderate-to-severe dry eye disease: a randomised controlled trial protocol

Introduction Dry eye disease (DED) is a common problem. Although the not fatal, it substantially reduces quality of life and creates high economic burden, especially in patients with moderate-to-severe DED. Several biological tear substitutes (eg, autologous serum (AS), platelet-rich plasma (APRP) platelet lysate) could effectively improve dry eyes. However, evidence on their comparative efficacy controversial. This study aims to compare 100% APRP AS drops Methods analysis The single-centre, double-blinded randomised, parallel, non-inferiority trial. One hundred thirty DED, aged 18–70 years will be recruited from outpatient clinic, Department Ophthalmology, Ramathibodi Hospital, Bangkok February 2021 January 2023. Patients randomised receive either or (1:1 ratio) for 4 weeks. primary outcomes are ocular surface index (OSDI) staining (OSS) evaluated using Oxford scale. Secondary fluorescein break-up time, Schirmer’s I test, meibomian gland parameters adverse events. Other measured include best-corrected visual acuity, intraocular pressure compliance. Ethics dissemination protocol any supplements used conducting this trial have been approved by Committee Faculty Medicine, Mahidol University (MURA2020/1930). Informed consent obtained all before entry. Results presented peer-reviewed journals international conferences. Trial registration number NCT04683796 .