Clinical evidence
Our eye screening technology has been widely studied by several research groups around the world. Find links to these studies here.
Diabetic eye disease
Several peer-reviewed studies confirm the diagnostic reliability and accuracy of Optomed handheld fundus camera image quality in detecting diabetic retinopathy.
Clinical Studies
Poster studies
Optomed Aurora is effective with high sensitivity and
specificity in detecting referable diabetic retinopathy
Sensitivity |
Specificity |
Sensitivity and Specificity values for detection of any diabetic retinopathy from Optomed Aurora
fundus images based on Midena E., et al. (2022)1 and Kubin AM., et al. (2021) 2.
Artificial Intelligence in Diabetic Eye Disease
Artificial Intelligence can be used for the early detection of diseases and conditions from the fundus. Our image quality has been validated to be suitable with several different AI algorithms and produce reliable results with high sensitivities and specificities in detecting diabetic retinopathy.
Clinical Studies
Exceptional clinical accuracy and precision in AI-powered diabetic retinopathy detection with Aurora AEYE3
Sensitivity |
Specificity |
Imageability |
This new FDA clearance is based on two large-scale prospective phase-III studies, in which Aurora AEYE with AEYE-DS algorithm demonstrated best-in-class efficacy and imageability. Diagnostic sensitivity was in the range of 92%-93% and specificity was in the range of 89%-94%. In both studies, over 99% of patients received a diagnostic result. The AI produced its diagnostic results using only a single image from each eye, rarely requiring dilation.
Neurology and Neuro-ophthalmology
Optomed handheld fundus camera can be successfully used in non-ophthalmology settings; the critical optic nerve examination with a handheld fundus camera can be performed with a high success rate.
Clinical Studies
Poster studies
High success rate in imaging of emergency department patients
Optomed handheld |
Traditional direct |
In a clinical study4) from Oulu University Hospital, retinal imaging of neurological emergency patients with
Optomed handheld fundus camera succeeded in 93% of cases whereas traditional direct ophthalmoscopy in 58%,
and the successful result was achieved more rapidly with handheld fundus camera.
Pediatric Ophthalmology
Optomed handheld fundus camera is well-suited for pediatric patients for all age groups. See how our camera has been utilized in different cases.
Poster Studies
Various Case Studies
Retinal Vasculature Visualization
Clinical Studies
Occupational Health
Clinical Studies
Clinical Studies with Smartscope
Case Studies with Smartscope
Poster studies with Smartscope
References:
1) Midena E, Zennaro L, Lapo C, Torresin T, Midena G, Pilotto E, Frizziero L. Handheld Fundus Camera for Diabetic Retinopathy Screening: A Comparison Study with Table-Top Fundus Camera in Real-Life Setting. J Clin Med. 2022 Apr 22;11(9):2352. doi: 10.3390/jcm11092352.
2) Kubin AM, Wirkkala J, Keskitalo A, Ohtonen P, Hautala N. Handheld fundus camera performance, image quality and outcomes of diabetic retinopathy grading in a pilot screening study. Acta Ophthalmol. 2021 Dec;99(8):e1415-e1420. doi: 10.1111/aos.14850.
3) https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240058.pdf
4) Alm M, Hautala N, Bloigu R, Huhtakangas J. Comparison of optic disc evaluation methods in neurology emergency patients.
Acta Neurol Scand. 2019;140(6):449-451. doi:10.1111/ane.13167