NCT05416268

Study to Compare the Diopsys NOVA and LKC RETeval Devices

An Objective Study to Compare the Diopsys NOVA and LKC RETeval Devices Using the Diopsys LID Electrodes and the LKC RETeval Self-Adhering Electrode Arrays

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Diopsys, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

To compare the Diopsys NOVA and LKC RETeval Devices using the Diopsys Lid Electrodes and LKC RETeval Self-Adhering Electrode Arrays.

Detailed description

This study is an open label, prospective study comparing the Diopsys NOVA and LKC RETeval devices using the Diopsys Lid Electrodes and the LKC RETeval Self-Adhering Electrode Arrays. Subjects will receive the PhNR test three times using the Diopsys device and Diopsys Electrodes. Next, subjects will receive the FL Flicker test three times using the Diopsys device and Diopsys Electrodes. There will be a short break (10 to 15 minutes), then subjects will receive the PhNR test three times using the Diopsys device with LKC Electrode Arrays, followed by the FL Flicker test three times using the Diopsys device with the LKC electrode arrays. Subjects will receive another short break (5 to 10 minutes), then receive the PhNR test three times using the LKC device with the LKC electrode arrays, followed by the FL Flicker test three times using the LKC device with the LKC electrode arrays.

Conditions

• Retinal Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Electroretinography	Two different electroretinogram devices (Diopsys NOVA and LKC RETeval Devices) will be evaluated with two different electrode arrays (Diopsys Lid Electrodes and LKC RETeval Self-Adhering Electrode Arrays).

Timeline

• Start date: 2022-05-04
• Primary completion: 2022-05-06
• Completion: 2022-05-06
• First posted: 2022-06-13
• Last updated: 2022-06-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study