Abstract
Purpose :
Currently, researchers are burdened with modifying injection devices for pre-clinical ophthalmic research. The need for modification introduces burden on researchers for the need to conduct additional decontamination steps including depyrogenation, sterilization, minimizing sub-visible particulates, etc. If the aforementioned is not conducted correctly, then the state/quality of the modified injection device could alter the outcome of the intended research. Primary need for modification of injection devices stems from non-availability of accurate dosing syringes that are compatible with fine needles rather than use pulled glass capillaries.
Methods :
Conducted literature review of procedures and materials used in ophthalmic injections in animal models and interviewed researchers conducting preclinical ophthalmic research. Testing of subvisible particle count per USP<789> and endotoxin content was measured. This device was further tested for relevant standard biological endpoints. Accuracy and precision of various dose volumes in the most relevant ranges were measured.
Results :
Demonstrated ability to inject 0.45 + 0.03 µL volume. Literature review indicated that injection volumes range between (0.5 - 10 µL) for research involving ophthalmic injections in adult Zebra Fish, Mice and Rats. ISO 80369-7:2021 compliance ensures that standard needles could be attached; hence needles as fine as 38G could be used precluding the need for pulled glass capillaries. Cost effectiveness was also demonstrated by avoiding need for researchers to perform sterilization, depyrogenation, decontamination and removal of leachable lubricants.
Conclusions :
The availability of an injection device for pre-clinical ophthalmic research that incorporates standard luer-lock needles and is sterilized and decontaminated may provide researchers with greater control over the surgical process and the quality of the study data. We have shown that such a device is feasible through gravimetric delivered volume measurements, decontamination studies and interviews with ophthalmic researchers.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.