A User-Preference Study on an Ophthalmic Injection Device to Facilitate Microliter Dosing for Intravitreal Injections.

Abstract

This work focused on understanding the current practice of the intravitreal injections (IVIs) and existing challenges for both patients and healthcare professionals with the ultimate goal of developing a combination device concept for intravitreal injections. Using a systematic approach, an initial user preference study was initiated that incorporated an online survey designed and conducted with retinologists from the EU countries (n = 25), followed by in-person interviews with national and international KOLs (n = 5). Multiple feasibility studies were conducted with focus on the unmet needs of key users such as handling characteristics and accuracy of the injection volume focusing on potential device solutions to address these unmet needs. Finally, laboratory testing and user experience evaluation of device potential concepts were used to find the best fitting device concept for injections of a fixed dose (0.05 ml) into the eye. Both qualitative evaluation and statistical analysis were used to study significant differences between the results of injection with device and standard of care. Compared to the manual IVI procedure, an automated device has the potential to increase safety for patients, decrease procedure times, allow for integrated data storage and documentation, and reduce costs for medical staff and expensive operating rooms.