RETeval Device Reference Data

RETeval Device Reference Data

O RETeval® device includes built-in, age-adjusted reference data for human use. Physicians now have valuable input to aid in their interpretation and assessment of patient test results.

The reference intervals come from an ongoing clinical trial, the RETeval  All Comers Trial (REACT), sponsored by LKC Technologies (More on ClinicalTrials.gov). The study was conducted in five locations in three states utilizing an IRB approved protocol. All subjects completed informed consent forms.

Firmware version 2.8.0 and higher on the RETeval device includes reference intervals for most photopic tests, please refer to the user manual more details. Contact customer support for download information.

Note that the manual states that LKC Sensor Strip skin electrodes must be used to show the reference intervals, and electrode type “Sensor Strip” must be selected at the start of the test.

At a glance, the study included:

  • 522 subjects
  • Age range 2-93
  • 244 subjects (aged 4- 85) have been classified as having normal vision, based on the following criteria:
    • BCVA of 20/25 (0.1 logMAR) or better
    • optic nerve cupping < 50%
    • no glaucoma or retinal diseases
    • no prior intraocular surgery (excepting non-complicated cataract or refractive surgery performed more than one year before)
    • IOP ≤ 20 mmHg
    • no diabetes, and no diabetic retinopathy as determined by the ophthalmologist or optometrist
  • Dilated and undilated normal subjects
    • Some subjects (n=77) were tested after artificial dilation, while others were tested with natural pupils and constant Troland stimuli that compensate for pupil size (n=167). Dilated subjects who did not dilate to at least 6 mm were excluded.