The device holds promise to impact unaddressed refractive error globally
BANGALORE, India, Oct. 12, 2022 /PRNewswire/ — At less than 570 gms, the Remidio Instaref R20 is arguably the world’s lightest and most portable auto refractometer based on the Shack-Hartmann Aberrometry technology. The product was unveiled, post FDA 510K registration, at the American Academy of Ophthalmology (AAO) 2022 conference in Chicago.
Instaref R20 provides an objective spherical and cylindrical correction on the examined eye in less than 5 seconds. The device holds promise to thereby disrupt the screening for uncorrected refractive error market, valued at over USD 1 billion.
WHO estimates ~2.2 billion people globally to have near or distant vision impairment. Unaddressed refractive error accounts for 44% of global vision impairment. Population growth and aging are expected to increase this risk. The portability of Instaref R20 allows an eye care professional to refract patients with limited mobility, such as patients who use wheelchairs, or for a bedside exam in a nursing home or even in the comfort of a patient’s home.
Instaref R20 is an open-view, mono-ocular design that negates fluctuations in measurement arising due to instrument-induced accommodation, as the examiner can choose an appropriate external target for the patient to fixate. Furthermore, the Instaref R20 is powered with an infrared imaging feedback and instrument tilt warning system to ensure appropriate alignment of eyes during the examination for accurate cylindrical values. A report can be printed instantly using a Bluetooth-enabled printer and transferred wirelessly to the Remidio Cloud EMR.
In a prospective clinical validation of the device among 132 adult participants, the mean bias of Instaref R20 against subjective refraction (SR) ranged between -0.08D and 0.06D for spherical equivalent (SE) and cylindrical values, and there were no statistically significant differences. Additionally, the Pearson value for SE exceeds 0.9, showing an excellent correlation.
Refractive error exams are especially challenging among kids. In another study, the device showed an excellent agreement among the 132 children compared to standard retinoscopy and SR, with a mean bias of less than -0.095D and 0.11D for SE and cylindrical values, respectively.
Studies have shown the Instaref R20 to be well correlated and closest to Subjective Refraction among all methods tested. These significant findings are submitted for publication and are currently under peer review.
Erik Hafkey, Chief Commercial Officer at Remidio Inc., said, “With the Instaref R20 being so conveniently portable and simple to use, it has the potential for large-scale community-based vision screening and prescribing refractive error corrections for adults and children. At a fraction of the cost of a standard desktop system, the Instaref R20 is an ideal solution to curb global vision impairment due to uncorrected refractive errors.”
Remidio is an innovative ISO 13485-certified medical devices company that seeks to impact preventable blindness by creating accessible technologies that are smart and simple to use. Remidio’s CE marked, and FDA 510k registered medical devices have helped screen and impact more than 7.5 million patients in 20 countries globally.
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