NCT03065881

RETeval All Comers Trial (REACT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 664 (actual)
• Sponsor: LKC Technologies, Inc. · Industry
• Sex: All
• Age: 6 Months – 95 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to collect electroretinogram ERG measurements from visually normal and abnormal subjects using the FDA cleared RETeval device (K142567). Data from the visually normal subjects will be used to create reference intervals for the device. Secondary objectives of the study are to provide ERG waveforms representative of disease states encountered and to analyze how well an ERG detects the various disease states encountered.

Conditions

• Retinal Disease, Electroretinogram

Interventions

Type	Name	Description
DEVICE	RETeval	The RETeval device measures the retina's electrical response to light, called an electroretinogram (ERG). The standards body ISCEV \[1\] recommends collecting normative data for ERGs to provide waveforms and statistically relevant measurements representing the range of ERGs from people with normal vision. LKC Technologies provides this information with their UTAS product line and wishes to collect such a database for the newest device: the RETeval device. As the RETeval device uses a different electrode to measure the ERG, the normal data for the UTAS product line is not transferable to the RETeval device. Ophthalmic practitioners would also like ERG examples of specific retinal disorders to help diagnose patients with abnormal ERGs. The RETeval device is FDA cleared (K142567),

Timeline

• Start date: 2017-02-13
• Primary completion: 2021-12-21
• Completion: 2021-12-21
• First posted: 2017-02-28
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study