Abstract

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. To review the effectiveness and safety of AS. We searched five databases and three registries up to September 30, 2022. Randomized clinical trials (RCT) comparing AS with artificial tears, saline, or placebo for participants with dry eye. 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. 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. We were unable to use all data due to unclear reporting. 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. 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.

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