Clinical trial NCT05416268: Study to Compare the Diopsys NOVA and LKC RETeval Devices
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Disease
Lead sponsor: Diopsys, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-13
Enrollment: 20
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: PhNR Latency (ms)
timeFrame: Day 1
Secondary outcomes:
measure: FL Latency (ms)
timeFrame: Day 1
Other outcomes:
measure: PhNR B-wave Latency (ms)
timeFrame: Day 1
measure: FL Magnitude (µV)
timeFrame: Day 1
measure: PhNR A-Wave Latency (ms)
timeFrame: Day 1
measure: PhNR Ratio
timeFrame: Day 1
measure: PhNR amplitude (µV)
timeFrame: Day 1
measure: PhNR B-Wave Amplitude (µV)
timeFrame: Day 1
measure: PhNR A-Wave Amplitude (µV)
timeFrame: Day 1
measure: FL Phase (deg)
timeFrame: Day 1
Locations:
city: Tahlequah
country: United States
facility: NSU Oklahoma College of Optometry
state: Oklahoma
Study officials:
affiliation: NSU Oklahoma College of Optometry
name: Nate Lighthizer, OD
role: PRINCIPAL_INVESTIGATOR
References: