Abstract
Purpose :
The purpose of this research was to develop and evaluate potential concepts for an intravitreal injections-aiding device with a systematic approach starting with user preference studies through concept development and evaluation by retinologists with extensive experience in IVIs.
Methods :
A user preference study was designed including an online survey with retinologists (n=25) followed by interviews with key opinion leaders, n=5. Potential device concepts were generated focusing on the unmet needs of key users such as handling characteristics and accuracy of the injection volume. Each device concept was evaluated by retinologists focusing on the identified unmet needs such as ease of handling, facilitating single hand operation and an accurate injection volume. Finally, laboratory testing was performed to study accuracy and repeatability of injections of a fixed 50µl dose followed by statistical analysis of the results of injection with device compared to the standard of care.
Results :
The results of the initial user preference information study helped clarify the primary unmet needs. A thorough evaluation of five potential device concepts by the study subject lead to a clear choice of preference . Injection volumes measured while using an injection-aiding device, demonstrated less dispersion around the target 50µL compared to those performed free-hand ie with a prefilled syringe. Anderson Darlin normality tests were performed to assure use of the right statistical methods and tests for further data analysis (Baseline, AD:0.205, P:0.866, Device, AD: 0.344, P:0.475). Descriptive statistics of the injection volume demonstrated a10% difference (P=0.002) between control measurements i.e. those performed by means of Prefilled Syringes and injections volumes delivered by an injection device. This difference is associated with tendency to inject higher volumes than intended.
Conclusions :
This study demonstrated that despite the advancements in drug therapeutics and the practice of intravitreal injections, there remain unmet needs that may be addressed by an automated injection device which can facilitate proper injection through improved handling and accuracy of the injection volume. Further testing of the most desirable device concepts is yet to be conducted to better understand the benefits of an IVI injection aiding device together with the experts in the field of retina diseases.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.