Testing a Novel Disposable Aqueous Humor Collector: An Approach to Improve Safety, Accuracy, and Efficiency.

Abstract

Aqueous humor (AH) is a useful biofluid for differential diagnosis and disease monitoring in a variety of ophthalmologic conditions. There are no commercially available medical devices specially designed for AH sampling. To improve the safety, accuracy, efficiency, and convenience of anterior chamber (AC) paracentesis, a novel vacuum-based disposable AH collector with a draw volume of 50 μL was designed. The safety and performance of this novel medical device was tested in New Zealand white rabbits. A commonly used 25G 1 mL syringe was used as the control device with target AH collection volume also intentionally set at 50 μL. The 36 eyes included in the study (18 rabbits) were divided into collector (R), collector (L), syringe (R), and syringe (L) subgroups, and each included 9 eyes (R/L indicates the paracentesis was performed by right/left hand). The mean AH volume collected by the collector (R), collector (L), syringe (R), and syringe (L) subgroups were 46.66 ± 3.37 (range: 39.20-50.40), 48.71 ± 2.88 (range: 45.00-53.60), 85.11 ± 18.70 (range: 64.00-123.50), and 80.68 ± 20.87 (range: 36.8-115.8) μL, respectively. The mean absolute deviation from the target volume and mean operation time of the collector subgroups were significantly lower than the syringe subgroups. Seidel tests revealed no AH leakage in any of the tested eyes. This study revealed that this novel AH collector facilitates one-handed AC paracentesis and accurate AH sampling, and appeared to be safer and more efficient than the traditional syringe-based techniques.