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Allogeneic and autologous serum eye drops: a pilot double-blind randomized crossover trial

Allogeneic and autologous serum eye drops: a pilot double-blind randomized crossover trial

Authors :
Pieter F. van der Meer
Rogier M Thurlings
Áine Honohan
Catharina A. Eggink
Sanne K Verbakel
Dirk de Korte
Jos Lorinser
Joannes F M Jacobs
Source :
Acta Ophthalmologica (2008), 99, 8, pp. 837-842, Acta Ophthalmologica (2008), 99, 837-842
Publication Year :
2021

Abstract

Contains fulltext : 243908.pdf (Publisher’s version ) (Open Access) PURPOSE: Serum eye drops (SEDs) are used to treat a variety of ocular surface defects. Serum eye drops (SEDs) are normally produced from the patient's blood. However, not all patients can donate sufficient or suitable blood, and logistics can be challenging. Allogeneic blood from voluntary blood donors does not have these disadvantages. Our aim was to evaluate whether autologous and allogeneic SEDs have comparable efficacy and tolerability. METHODS: In a prospective, double-blind crossover trial, patients with severe dry eyes were randomized to first receive autologous SEDs for one month, followed by one-month washout, before receiving allogeneic SEDs for 1 month; or receive the SED preparations in reverse order. The Ocular Surface Disease Index (OSDI) was the primary endpoint, and various secondary endpoints were determined. A linear mixed model with random intercept for each patient was applied per treatment group to compare the pre- and postoutcome measurements. RESULTS: Nineteen patients were enrolled, of whom 15 completed the trial. When autologous SEDs were used, the mean ± SD OSDI improved from 62 ± 19 to 57 ± 18. For allogeneic SEDs, the OSDI changed from 59 ± 20 to 56 ± 23. The estimated mean difference (95% confidence interval) was -4.2 (-9.5 to 1.2) for autologous and -4.5 (-9.8 to 0.9) for allogeneic SEDs (both, not significant). Adverse events were mild and resolved completely. CONCLUSION: Autologous and allogeneic SEDs have comparable efficacy and tolerability for use in patients with severe dry eyes. Allogeneic SEDs are therefore an attractive alternative for patients who need SEDs but are clinically or logistically unable to donate blood.

Details

ISSN :
17553768 and 1755375X
Volume :
99
Issue :
8
Database :
OpenAIRE
Journal :
Acta ophthalmologica
Accession number :
edsair.doi.dedup.....6194fad97f527e3e758f90d16f84f70a