Autologous Serum in DES
Trial question
What is the effect of autologous serum eye drops in patients with dry eye syndrome?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
61.0% female
39.0% male
N = 232
232 patients (141 female, 91 male).
Inclusion criteria: patients with moderate-to-severe dry eye syndrome.
Key exclusion criteria: history of allergy or adverse reactions to blood products or artificial tears; eye surgery; trauma within the past 6 months; ocular infection or inflammation within the past 3 months.
Interventions
N=116 autologous serum eye drops (application of one drop of autologous serum eye drops to each eye, QID, for 12 weeks).
N=116 artificial tears (application of one drop containing 0.1% sodium hyaluronate to each eye QID for 12 weeks).
Primary outcome
Reduction in Ocular Surface Disease Index score at 12 weeks
26.4 points
16.1 points
26.4 points
19.8 points
13.2 points
6.6 points
0.0 points
Autologous serum eye
drops
Artificial
tears
Significant
increase ▲
Significantly greater reduction in Ocular Surface Disease Index score at 12 weeks (26.4 points vs. 16.1 points; AD 10.3 points, 95% CI 7 to 13.6).
Secondary outcomes
Significantly greater improvement in tear break-up time at 12 months (2.4 seconds vs. 0.6 seconds; MD 1.8, 95% CI 1.2 to 2.4).
Significantly greater improvement in Schirmer I test at 12 weeks (4.6 mm/5 min vs. 1.5 mm/5 min; MD 3.1, 95% CI 2.3 to 3.9).
Significantly greater reduction in corneal fluorescein staining score at 12 weeks (3.4 points vs. 1.9 points; MD 1.5, 95% CI 1.1 to 1.9).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients with moderate-to-severe dry eye syndrome, autologous serum eye drops were superior to artificial tears with respect to reduction in Ocular Surface Disease Index score at 12 weeks.
Reference
Na Zheng, Si-Quan Zhu. Randomized controlled trial on the efficacy and safety of autologous serum eye drops in dry eye syndrome. World J Clin Cases. 2023 Oct 6;11(28):6774-6781.
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