Retinal Disease
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTElectroretinography
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).
Sponsors
Diopsys, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PhNR Latency (ms) | Day 1 | Change in ERG PhNR Latency (ms) parameter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FL Latency (ms) | Day 1 | Change in ERG FL Latency (ms) parameter |
Other
| Measure | Time frame | Description |
|---|---|---|
| PhNR A-Wave Latency (ms) | Day 1 | Change in ERG PhNR A-Wave Latency (ms) parameter |
| PhNR Ratio | Day 1 | Change in ERG PhNR Ratio parameter |
| PhNR amplitude (µV) | Day 1 | Change in ERG PhNR amplitude (µV) parameter |
| PhNR B-wave Latency (ms) | Day 1 | Change in ERG PhNR B-wave Latency (ms) parameter |
| PhNR A-Wave Amplitude (µV) | Day 1 | Change in ERG PhNR A-Wave Amplitude (µV) parameter |
| FL Phase (deg) | Day 1 | Change in ERG FL Phase (deg) parameter |
| PhNR B-Wave Amplitude (µV) | Day 1 | Change in ERG PhNR B-Wave Amplitude (µV) parameter |
| FL Magnitude (µV) | Day 1 | Change in ERG FL Magnitude (µV) parameter |
Countries
United States
Outcome results
None listed