Autologous Serum Eye Drops for Dry Eye: Systematic Review

Abstract

Background Dry eye is a common condition with serious implications worldwide. The unique composition of autologous serum eye drops (AS) has been hypothesized as a possible treatment. Objectives To review the effectiveness and safety of AS. Data Sources We searched five databases and three registries up to September 30, 2022. Study Eligibility Randomized clinical trials (RCT) comparing AS with artificial tears, saline, or placebo for participants with dry eye. Study Appraisal and Synthesis Methods We adhered to Cochrane methods for study selection, data extraction, risk of bias assessment, and synthesis. We used the GRADE framework to evaluate the certainty of evidence. Results We included six RCTswith 116 participants. Four trials compared AS with artificial tears. We found low-certainty evidence that AS may improve symptoms (0-100 pain scale) after two weeks of treatment compared with saline (MD -12.00, 95% CI: -20.16 to -3.84; 1 RCT, 20 participants). Ocular surface outcomes (corneal staining, conjunctival staining, tear break-up time, Schirmer’s test) were inconclusive. Two trials compared AS with saline. Very low-certainty evidence suggested that Rose Bengal staining (0-9 scale) may be slightly improved after four weeks of treatment compared with saline (MD -0.60, 95% CI: -1.11 to -0.09; 35 eyes). None of the trials reported outcomes of corneal topography, conjunctival biopsy, quality of life, economic outcomes, or adverse events. Limitations We were unable to use all data due to unclear reporting. Conclusions The effectiveness of AS is uncertain based on current data. Symptoms improved slightly with AS compared with artificial tears for two weeks. Staining scores improved slightly with AS compared with saline, with no benefit identified for other measures. Implications of Key Findings High-quality, large trials enrolling diverse participants with varying severity are needed. A core outcome set would allow for evidence-based treatment decisions consistent with current knowledge and patient values.

Interventions for Dry Eye

“…Autologous serum at various concentrations may improve both dry eye symptoms and tear film stability when compared with artificial tears. However, a recently updated review reported that changes in tear film stability measurements were not clinically important and concluded that there is insufficient evidence to recommend autologous serum use for dry eye . Variations in eligibility criteria regarding ocular surface disease definitions and the analysis methods implemented to handle cross-over trial results may explain differences in reported summary effect estimates and conclusions across autologous serum reviews.…”

Five-Year Risk and Safety Profile of Autologous Serum Eye Drop Therapy

“…Despite the frequent use of unpreserved AS eye drops in outpatients around the world, there are only very few reports on infectious complications of AS eye drops [7]. A recent systematic review of AS therapy for dry eye showed that none of the six included randomized control trials reported on the safety or adverse effect of AS eye drops [8]. Hence, the aim of this study was to analyze the risk for infectious complications of unpreserved AS eye drops when used in an outpatient setting.…”