Study to Compare the Diopsys NOVA and LKC RETeval Devices

NCT ID: NCT05416268

Last Updated: 2022-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-04
• Study Completion Date: 2022-05-06

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.

Conditions

Retinal Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diopsys NOVA and Diopsys Electrodes

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.

Group Type: OTHER

Electroretinography

Intervention Type: 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).

Diopsys device with LKC Electrode Arrays

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.

Group Type: OTHER

Electroretinography

Intervention Type: 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).

LKC device with the LKC electrode arrays

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.

Group Type: OTHER

Electroretinography

Intervention Type: 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).

Interventions

Electroretinography

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).

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Diopsys, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nate Lighthizer, OD

Role: PRINCIPAL_INVESTIGATOR

NSU Oklahoma College of Optometry

Locations

NSU Oklahoma College of Optometry

Tahlequah, Oklahoma, United States

Countries

United States

Other Identifiers

200

Identifier Type: -

Identifier Source: org_study_id