A study by Retina Health Center examining the comfort and efficiency of a new guarded injection device used for targeted application of medication for retinal disorders has been published in the November/December issue of OSLI Retina, a peer-reviewed clinical publication. In July 2012 Retina Health Center began clinical trials, enrolling 70 consenting patients, to evaluate if the device is faster and/or more comfortable than existing techniques that use a lid speculum.
According to the study, use of the guarded injection device without a lid speculum reduces the injection time by one-third, and saves considerable staff time that would be needed to process the lid speculum. However, in reviewing pain scores of participating patients, there was no significant difference in patient pain levels when comparing the two needles, though the results show a trend toward greater comfort using the guarded injection device. Similarly, while there was no difference in rates of infections using the two devices, the prevention of needle contamination using the guarded device, despite documented video contact with an eyelid, suggests it has a protective effect.
“These results suggest that this new device addresses an unmet need by providing a simple way of reducing injection times and theoretically reducing risk of injection from direct contact with eyelids, aerosolized saliva and other environmental contaminants during injection,” said study author and Retina Health Center Director Dr. Alexander Eaton. “We’re pleased with these results. For patients with wet age related macular degeneration and other retinal disorders who undergo injections up to every four weeks, this device should help to improve the patient care experience by reducing the injection time.”
Recently developed by Retina Health Center in collaboration with other researchers, the guarded injection device incorporates a small gauge needle covered by a thin protective sleeve designed to protect the needle from contamination risks before and during the injection such as aerosolized saliva droplets from speech or breathing, as well as from the eyelashes or other external contaminants.
Dr. Eaton will share additional study results with ophthalmologists from around the world Dec. 6-7 at the Asia Pacific Vitreo-retina Society Congress in Japan.
An estimated 10 million people worldwide receive eye injections every year. This number has increased considerably over the last few years and is expected to continue to increase in the foreseeable future. The most serious complication of intravitreal injections (IVIs) is endophthalmitis, with incidences of infection rates being reported between 0.02 percent and 0.87 percent. While the incidence of endophthalmitis following IVIs is low, the outcome tends to be poor.
This is the first of a number of products being developed by I-Tech JV Development Company which address issues with intravitreal injections to reach clinical trial. By combining a team of retinal thought leaders and experienced device designers, the I-Tech JV Development Company is able to rapidly assess and develop products to meet evolving retina needs.
For more information on the latest studies or to make an appointment, call 239-337-3337 in Fort Myers or 239-793-5200 in Naples.