Efficacy and safety of 20% and 100% autologous serum eye drops in patients with severe dry eye disease: a prospective, blinded, randomized, crossover study

IF 6.6 1区医学 Q1 OPHTHALMOLOGY

Ocular Surface Pub Date : 2026-10-01 Epub Date: 2026-10-03 DOI:10.1016/j.jtos.2026.10.001

Dimitri Roels, Ineke van Gremberghe, Liesbeth Huys, Jerina Boelens, Joke Deprez, Isabelle Peene, Dirk Elewaut, Bart P. Leroy, Ilse Claerhout, Tessa Kerre

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引用次数: 0

Abstract

Purpose

To evaluate the efficacy and safety of 20% and 100% autologous serum eye drops (ASED), compared to preservative-free artificial tears (PFAT), as a treatment for severe dry eye disease (DED).

Methods

Forty-six patients with severe DED were randomized to receive PFAT, ASED 20% and ASED 100% for 8 weeks in a crossover study design with a 2-week washout period. The Ocular Surface Disease Index (OSDI) questionnaire was used as primary outcome measure. Secondary outcomes were non-invasive tear break-up time (tBUT), best-corrected visual acuity, Schirmer 1 test, ocular surface staining (OSS) using the Sjögren's International Collaborative Clinical Alliance (SICCA) OSS score, tBUT, conjunctival injection score and Meibomian gland dysfunction grading. Additionally, serum and tear cytokine analysis and microbiological cultures were performed.

Results

Mean improvement in OSDI-score compared to baseline was 3.0 for PFAT (p = 0.35), 12.3 for ASED 20% (p < 0.001) and 19.5 for ASED 100% (p < 0.001). Mean improvement in SICCA OSS was 0.96 for PFAT (p = 0.002), 1.63 for ASED 20% (p < 0.001) and 1.95 for ASED 100% (p < 0.001). No significant differences between treatments were found for all other secondary outcomes. Cultures were positive in more than half of the PFAT and ASED vials, with the majority containing commensal flora. Analysis of tear cytokines suggested that ASED promotes a less inflammatory ocular environment than PFAT.

Conclusions

ASED 100% provided the greatest improvement in OSDI and SICCA OSS scores compared to baseline, supporting the clinical value of higher concentrations of autologous serum.

查看原文本刊更多论文

20%和100%自体血清滴眼液治疗严重干眼病的疗效和安全性：一项前瞻性、盲法、随机、交叉研究

目的评价20%和100%自体血清滴眼液（ASED）与不含防腐剂的人工泪液（PFAT）治疗重度干眼病（DED）的疗效和安全性。方法采用交叉研究设计，46例重度DED患者随机接受PFAT， 20%和100%的ASED治疗，为期8周，洗脱期为2周。眼表疾病指数（OSDI）问卷作为主要结局指标。次要结果为无创泪液破裂时间（tBUT）、最佳矫正视力、Schirmer 1试验、眼表染色（OSS）（使用Sjögren的国际临床合作联盟（SICCA） OSS评分）、tBUT、结膜注射评分和睑板腺功能障碍评分)。此外，进行血清和泪液细胞因子分析和微生物培养。结果与基线相比，PFAT组的osdi评分平均改善为3.0 (p = 0.35)，ASED组为12.3 (p <； 0.001)，ASED组为19.5 （p <； 0.001）。PFAT组SICCA OSS的平均改善为0.96 (p = 0.002)，ASED 20%组为1.63 (p <； 0.001)，ASED 100%组为1.95 （p <； 0.001）。在所有其他次要结果中，两种治疗之间没有发现显著差异。超过一半的PFAT和ASED小瓶培养阳性，其中大多数含有共生菌群。泪液细胞因子的分析表明，与PFAT相比，ASED促进了更少的炎症性眼部环境。结论与基线相比，100%的自体血清对OSDI和SICCA OSS评分的改善最大，支持了较高浓度的自体血清的临床价值。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Ocular Surface 医学-眼科学

CiteScore

11.60

自引率

14.10%

发文量

审稿时长

39 days

期刊介绍： The Ocular Surface, a quarterly, a peer-reviewed journal, is an authoritative resource that integrates and interprets major findings in diverse fields related to the ocular surface, including ophthalmology, optometry, genetics, molecular biology, pharmacology, immunology, infectious disease, and epidemiology. Its critical review articles cover the most current knowledge on medical and surgical management of ocular surface pathology, new understandings of ocular surface physiology, the meaning of recent discoveries on how the ocular surface responds to injury and disease, and updates on drug and device development. The journal also publishes select original research reports and articles describing cutting-edge techniques and technology in the field. Benefits to authors We also provide many author benefits, such as free PDFs, a liberal copyright policy, special discounts on Elsevier publications and much more. Please click here for more information on our author services. Please see our Guide for Authors for information on article submission. If you require any further information or help, please visit our Support Center