- Title
- Efficacy of 100% autologous platelet-rich plasma and 100% autologous serum in dry eye disease: a randomised controlled trial
- Creator
- Jongkhajornpong, Passara; Lekhanont, Kaevalin; Rattanasiri, Sasivimol; Numthavaj, Pawn; Mckay, Gareth; Attia, John; Thakkinstian, Ammarin
- Relation
- BMJ Open Ophthalmology Vol. 9, Issue 1, no. e001857
- Publisher Link
- http://dx.doi.org/10.1136/bmjophth-2024-001857
- Publisher
- BMJ Group
- Resource Type
- journal article
- Date
- 2024
- Description
- 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.
- Subject
- clinical trial; ocular surface; tears; treatment medical
- Identifier
- http://hdl.handle.net/1959.13/1516683
- Identifier
- uon:57013
- Identifier
- ISSN:2397-3269
- Rights
- © Author(s) (or their employer(s)) 2024. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license https://creativecommons.org/licenses/by-nc/4.0/
- Language
- eng
- Full Text
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