NSU Oklahoma College of Optometry
Tahlequah, Oklahoma, 74464, United States
NCT Number: NCT05416268
To compare the Diopsys NOVA and LKC RETeval Devices using the Diopsys Lid Electrodes and LKC RETeval Self-Adhering Electrode Arrays.
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Notify Me22 year and older
All sexes
Interventional
Not applicable
Tahlequah, Oklahoma, 74464, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Other names: Electrode Arrays
Time frame: Day 1
Change in ERG PhNR Latency (ms) parameter
Time frame: Day 1
Change in ERG FL Latency (ms) parameter
Time frame: Day 1
Change in ERG PhNR B-wave Latency (ms) parameter
Time frame: Day 1
Change in ERG FL Magnitude (µV) parameter
Time frame: Day 1
Change in ERG PhNR A-Wave Latency (ms) parameter
Time frame: Day 1
Change in ERG PhNR Ratio parameter
Time frame: Day 1
Change in ERG PhNR amplitude (µV) parameter
Time frame: Day 1
Change in ERG PhNR B-Wave Amplitude (µV) parameter
Time frame: Day 1
Change in ERG PhNR A-Wave Amplitude (µV) parameter
Time frame: Day 1
Change in ERG FL Phase (deg) parameter
Diopsys, Inc.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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