RETeval®

Hand-Held, Full-Field ERG

RETeval is the only FDA 510(k) cleared,  non-mydriatic*  full-field ERG device that is easier to use than you might think.

Many diseases and disorders affect various cell populations in the retina, and ERG testing provides an objective, non-invasive method of evaluating retinal function.

Hand-held, battery-powered & easy to use anywhere, all day, with easy interpretation aided by a 500+ subject, age-matched normative database.

*Dilation and documenting pupil size is required for other ffERG devices.


Clinical Applications

DR, glaucoma, CRVO, acquired & inherited retinal diseases, pediatric nystagmus1

Retinal assessment prior to cataract surgery where PIOLs are considered

1. RETeval is not cleared for the specific diagnosis of any condition.


Clinical Benefits

Objectively assess 120 degrees of retinal function

Compare structure & function, especially when subjective SAP does not correlate

Can be used on infants without sedation and well tolerated by adults, young children & the elderly


Regulatory

FDA 510(k) Cleared | CPT Codes 92273 & 95930

CE Marked

 Distributed by Konan in the USA only

The First and Only FDA Cleared, Non-Mydriatic, Hand-Held, Full-Field ERG Device

Portable, powerful ERG testing in the palm of your hand. Easily integrates into your current workflow.

RETeval is efficient and intuitive to administer, requires minimal (if any) changes in workflow, and allows physicians to perform visual electrophysiology testing almost anywhere.

Utilizing a miniature integrated Ganzfeld with multiple flash and flicker protocols, RETeval provides an objective, robust assessment of retinal function.

Full-field ERG testing is complementary to OCT, color vision diagnostics (ColorDx®), pattern VEP/ERG (EvokeDx®), retinal imaging and subjective SAP.

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New to Visual Electrophysiology or Thinking About a Change?

Have you have been considering adding electrodiagnostics to your practice but thought it was too complex or out of reach due to space limitations, cost or staffing, or are you dissatisfied with your current device?

RETeval is an affordable, practical and robust solution that helps bridge the gap between structure and function that easily integrates into your current practice flow.

Key Features:

  • Age matched, normative data for most protocols

  • Integrated pupilometer that allows for testing of dilated and un-dilated pupils (based on patient/physician’s needs) while maintaining constant luminance

  • Integrated Ganzfeld bowl with a soft eyecup that is comfortable for patients while minimizing interference from external light sources

  • High quality, robust materials with excellent shielding from electromagnetic interference

  • Ergonomic, hand-held, mobile

  • Reliable and repeatable results

  • Suitable for adult and pediatric patients

  • Perform up to 70 tests between charges

  • Patented, easy to apply Sensor-Strip electrodes, or use the corneal electrode of your choice

  • Intuitive user-interface

  • Immediate results displayed on the device

  • Downloadable PDF report

  • Ability to run full-field ERG tests adhering to ISCEV standards, including all extended protocols and optional custom protocols

Clinical Applications

Objectively assess diabetic retinopathy1,2, glaucoma3,7, CRVO4, acquired and inherited retinal diseases5,6, pediatric nystagmus8. Additionally, changes in color vision measured by color vision diagnostics such as ColorDx CCT HD, may suggest that additional assessment of retinal function with an ERG device might be an appropriate next step.


1. Maa et al. A novel device for accurate and efficient testing for vision-threatening diabetic retinopathy. Journal of Diabetes and Its Complications, 2015.
2. Fukuo et al. Screening for diabetic retinopathy using new mydriasis-free, full-field flicker ERG recording device. Scientific Reports, 2016.
3. Wu et al. Photopic negative response obtained using a handheld electroretinogram device: determining the optimal measure and repeatability, Translational Vision Science & Technology, 2016.
4. Yasuda et al. Flicker electroretinograms before and after intravitreal ranibizumab injection in eyes with central retinal vein occlusion. Acta Ophthalmologica, 2015.
5. Nakamura et al. Evaluation of cone function by a handheld non-mydriatic flicker electroretinogram device. Clinical Ophthalmology, 2016.
6. Ullah et al. Mutations in phosphodiesterase 6 identified in familial cases of retinitis pigmentosa. Human Genome Variation, 2016.
7. Preiser et al. Photopic Negative Response versus Pattern Electroretinogram in Early Glaucoma. Investigative Ophthalmology & Visual Science, 2013.
8. Grace, et al. Portable non-sedated electroretinogram evaluation of children with nystagmus in the pediatric ophthalmology clinic. Journal of AAPOS, 2016.

RETeval is a registered trademark of LKC Technologies, Inc. Distributed in the USA by Konan Medical.