Abstract
OBJECTIVE: The 0bjective is to compare treatment effects between undiluted autologous platelet-rich plasma (APRP) and autologous serum (AS) in patients with moderate-to-severe dry eye disease (DED).
METHODS AND ANALYSIS: A single-centre, randomised, double-masked, non-inferiority clinical trial was conducted. 96 adult DED patients with an Ocular Surface Disease Index (OSDI) Score of ≥23 and/or Oxford staining grade of ≥2 were randomised to receive either 100% APRP (n=48) or 100% AS (n=48) for 4 weeks. Primary outcomes included OSDI Score and ocular surface staining measured by Oxford grading scale at 4 weeks. Secondary outcomes included fluorescein tear break-up time, Schirmer's test, meibum quality and expressibility, and adverse events. The 95% CI for the mean difference in OSDI scores between groups was estimated to assess non-inferiority of the OSDI score at a prespecified margin of 4.18 points.
RESULTS: At week 4, there was no significant difference in decreased OSDI scores between groups, with the mean difference (100% APRP-100% AS) of 1.41 (95% CI -1.26, 4.08, p=0.299). The upper limit was less than the prespecified margin, indicating non-inferiority of 100% APRP vs 100% AS. The probabilities of achieving an Oxford grade 0-1 after treatment were not significantly different between groups, with an OR of 0.61 (95% CI 0.25, 1.52, p=0.288). No significant differences in secondary outcomes were observed between groups.
CONCLUSION: In the short-term, 100% APRP was not inferior to 100% AS in reducing dry eye symptoms and ocular surface staining in moderate-to-severe DED.
TRIAL REGISTRATION NUMBER: NCT04683796.
Original language | English |
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Article number | e001857 |
Number of pages | 9 |
Journal | BMJ Open Ophthalmology |
Volume | 9 |
Issue number | 1 |
DOIs | |
Publication status | Published - 08 Oct 2024 |
Bibliographical note
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.Keywords
- Humans
- Platelet-Rich Plasma
- Dry Eye Syndromes/therapy
- Female
- Male
- Middle Aged
- Double-Blind Method
- Tears/metabolism
- Treatment Outcome
- Serum/chemistry
- Adult
- Aged