Study to Compare the Diopsys NOVA and LKC RETeval Devices

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

Detailed Description
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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.

Official Title
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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

Conditions
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Retinal Disease

Intervention / Treatment
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* Diagnostic Test: Electroretinography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female at least 22 years of age on day of enrollment BCVA letter score of 75 or better (Snellen equivalent of 20/32 or better) on day of enrollment Eyes are healthy/normal based on prior examinations, record review, and/or patient intake questions. Subject has not been diagnosed with any ocular pathology that could affect ERG results. Able to communicate well with the Investigator and able to understand and comply with the requirements of the study Informed of the nature of this study and has provided written, informed consent in accordance with institutional, local and national regulatory guidelines Exclusion Criteria: A spherical refraction outside + 5.0 D and cylinder correction outside + 3.0 D on day of enrollment Intraocular surgery (except non-complicated cataract or refractive surgery performed more than 1 year before enrollment) Any prior macular or panretinal photocoagulation laser treatment History of ophthalmic or neurologic condition known to affect visual function Inability to obtain a reliable ERG test History of Diabetic retinopathy History of Glaucoma History of ARMD History of seizure disorder Has an open sore(s) or dermatological condition that may come in contact with the electrodes/electrode arrays In the opinion of the Investigator, is unlikely to comply with the study protocol

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Diopsys NOVA and Diopsys Electrodes<br>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. | Diagnostic Test: Electroretinography<br>* 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).<br>* Other names: Electrode Arrays;|
| Other: Diopsys device with LKC Electrode Arrays<br>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. | Diagnostic Test: Electroretinography<br>* 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).<br>* Other names: Electrode Arrays;|
| Other: LKC device with the LKC electrode arrays<br>Subjects will 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. | Diagnostic Test: Electroretinography<br>* 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).<br>* Other names: Electrode Arrays;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PhNR Latency (ms) | Change in ERG PhNR Latency (ms) parameter | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FL Latency (ms) | Change in ERG FL Latency (ms) parameter | Day 1 |