Study to Compare the Diopsys NOVA and LKC RETeval Devices

NCT05416268 | Completed FDA Device

• 1 other identifier: 200
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Retinal Disease

Outcome Measures

Primary Outcomes (1)

• PhNR Latency (ms)

  Change in ERG PhNR Latency (ms) parameter

  Day 1

Secondary Outcomes (1)

• FL Latency (ms)

  Day 1

Other Outcomes (8)

• PhNR B-wave Latency (ms)

  Day 1

• FL Magnitude (µV)

  Day 1

• PhNR A-Wave Latency (ms)

  Day 1

Study Arms (3)

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.

Diagnostic Test: Electroretinography

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.

Diagnostic Test: Electroretinography

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.

Diagnostic Test: Electroretinography

Interventions

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).

Also known as: Electrode Arrays

Diopsys NOVA and Diopsys Electrodes; Diopsys device with LKC Electrode Arrays; LKC device with the LKC electrode arrays

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diopsys, Inc.: lead

Study Sites (1)

NSU Oklahoma College of Optometry

Tahlequah, Oklahoma, 74464, United States

Location

MeSH Terms

Conditions

Retinal Diseases

Interventions

Electroretinography

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Nate Lighthizer, OD

  NSU Oklahoma College of Optometry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 13, 2022
• Study Start: May 4, 2022
• Primary Completion: May 6, 2022
• Study Completion: May 6, 2022
• Last Updated: June 14, 2022

Record last verified: 2022-06

Locations

US (1)