Description

Fundus examination is a fundamental test for the evaluation of many diseases. Specifically, diabetic retinopathy (DR) is one of the most important complications in diabetics and has a significant impact on health care costs. Within 20 years of diagnosis, most people with diabetes mellitus have some degree of DR, which increases their risk of blindness 25-fold compared to people without diabetes mellitus. In the early stages, patients with diabetic retinopathy may have no symptoms, but as the disease progresses it can lead to a decrease in visual acuity that in some cases is irreversible. Therefore, early identification and treatment of DR in asymptomatic phases can reduce the incidence of blindness or prevent the progression of DR, so it is very important to perform periodic fundus examinations, assessing the retina, in diabetic patients. In this scenario, the direct ophthalmoscope (DO) is available both in AP and other specialties for fundus examinations.

Our open retinoscope (OR) is a device designed for fundus (retina) examination, which combines a light source (LED) with the Volk indirect ophthalmic lens (biconvex lens) that allows the health professional to evaluate a patient’s retina more easily and with a much larger field of view than with any OD. This device allows the coupling of any smartphone model to collect the images obtained during the examination. Today there are similar devices available on the market, such as PanOptic, iExamine or EyeGo. However, these adapters have a number of disadvantages, such as they can only be connected to a specific version of smartphone, they are expensive and they are not easy to use.

The technology is currently owned by the San Juan de Dios Aljarafe Hospital and the Andalusian Health Service. It is intended to be granted a European patent (EP15875290A) and a US patent has been granted (US10799114B2).

The main advantages of this product are:

(i) It allows the doctor to evaluate a larger visual field than with any direct ophthalmoscope and with sufficient clarity to obtain clinical conclusions;
(ii) It can be adapted to any smartphone model;
(iii) It is easy to use and has low manufacturing costs;
(iv) It can be used autonomously, without the need to connect to a smartphone;
(v) ​​It has a support system on the patient that allows stabilizing the images obtained.

The incorporation of this solution into a population screening program would increase coverage rates in the target population and reduce the variability of these rates when they depend on reduced accessibility. Inclusion in a systematic screening program is identified as the critical element for the early diagnosis of diabetic retinopathy and the application of specific treatments that have proven to be effective in reducing blindness rates in the diabetic population.

-TRL 6-7. Functional prototype clinically validated in different retinal pathologies (diabetic retinopathy) and different settings (emergency rooms and ophthalmology).

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