Pediatric Eye Test Equipment FAQs

iScreen Vision, a pediatric photoscreening device, captures two digital “red reflex” images of a child’s eyes. A “normal” red reflex means light is passing through the eyes normally and focusing on the retina in a way that creates symmetrical images – oftentimes a reddish color – in both eyes. Red reflex images that are are asymmetrical, have dark spots, display a white-colored crescent-shaped reflex, or don’t create a red reflex at all can all be indications of various eye abnormalities.

The iScreen Vision Screener 3000 is a specialized pediatric ophthalmic camera, known as a photoscreener, that is designed to capture digital images of red reflex and corneal light reflex images from the eyes. Physicians may also use an ophthalmoscope to capture a red reflex or corneal light reflex; however the use of an ophthalmoscope requires specialized training, can be time-consuming, and can be challenging under certain conditions, particularly with younger children who won’t sit still. In addition, a photoscreener captures a permanent image of the red reflex and corneal light reflex, while an ophthalmoscope does not create any digital imagery of the eyes.

In addition to photoscreeners, there are many other types of eye test machines or eye test equipment, which are designed for different purposes, such as measuring refraction of the eyes. These include retinal cameras, which capture a digital image of the light-sensitive tissue at the back of the eye, known as the retina; autorefractors (also called auto refractors or handheld autorefractors or auto-refractors or portable autorefractors), which are devices designed to measure refraction in the eyes. The refraction of light is what allows our eyes to focus correctly. A refraction test, also known as an eye test or vision test, is the test that an eye doctor performs to check a person’s vision or eyesight. Refraction tests are designed to detect refractive errors, which occur when eye problems such as myopia (nearsightedness), hyperopia (far sightedness) or astigmatism (irregularly shaped cornea) prevent light from focusing properly on the retina.

No, retinal cameras, which take images of the retina – the light-sensitive tissue at the back of the eye – are a different type of camera than the iScreen Vision Screener 3000 camera, which is called a photoscreener and is designed to optimize red-reflex and corneal-light reflex images from the eyes.

Yes. iScreen Vision, a photoscreener, was cleared to begin marketing by the FDA through the 510(k) process under a classification as ophthalmic camera. Products under this classification are Class II devices and are required to demonstrate their safety and efficacy to the FDA as part of the 510(k) process. The FDA identifies an ophthalmic camera as “an AC-powered device intended to take photographs of the eye and the surrounding area.”

Some ophthalmic devices, such as autorefractors (also known as auto-refractors or auto refractors or hand held or portable autorefractors) classify themselves as ophthalmic refractometers –– and are Class I devices. The FDA identifies ophthalmic refractometers as “an automatic AC-powered device that consists of a fixation system, a measurement and recording system, and an alignment system intended to measure the refractive power of the eye by measuring light reflexes from the retina.”Ophthalmic refractometers are exempt from FDA premarket notification procedures and are not subject to the same level of regulatory control by the FDA.

According to the FDA, “Class I devices are deemed to be low risk and are therefore subject to the least regulatory controls. For example, dental floss is classified as Class I device. Class II devices are higher risk devices than Class I and require greater regulatory controls to provide reasonable assurance of the device’s safety and effectiveness.” (Source:http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194438.htm)