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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diopsys NOVA and Diopsys Electrodes | Other | 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. |
|
| Diopsys device with LKC Electrode Arrays | Other | 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. |
|
| LKC device with the LKC electrode arrays | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroretinography | Diagnostic Test | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| PhNR Latency (ms) | Change in ERG PhNR Latency (ms) parameter | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| FL Latency (ms) | Change in ERG FL Latency (ms) parameter | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| PhNR B-wave Latency (ms) | Change in ERG PhNR B-wave Latency (ms) parameter | Day 1 |
| FL Magnitude (µV) | Change in ERG FL Magnitude (µV) parameter |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nate Lighthizer, OD | NSU Oklahoma College of Optometry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NSU Oklahoma College of Optometry | Tahlequah | Oklahoma | 74464 | United States |
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| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D004596 | Electroretinography |
| ID | Term |
|---|---|
| D003941 | Diagnostic Techniques, Ophthalmological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
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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.
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| Day 1 |
| PhNR A-Wave Latency (ms) | Change in ERG PhNR A-Wave Latency (ms) parameter | Day 1 |
| PhNR Ratio | Change in ERG PhNR Ratio parameter | Day 1 |
| PhNR amplitude (µV) | Change in ERG PhNR amplitude (µV) parameter | Day 1 |
| PhNR B-Wave Amplitude (µV) | Change in ERG PhNR B-Wave Amplitude (µV) parameter | Day 1 |
| PhNR A-Wave Amplitude (µV) | Change in ERG PhNR A-Wave Amplitude (µV) parameter | Day 1 |
| FL Phase (deg) | Change in ERG FL Phase (deg) parameter | Day 1 |