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Study to Compare the Diopsys NOVA and LKC RETeval Devices

Sponsor
Diopsys, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05416268
Collaborator
(none)
20
Enrollment
1
Location
3
Arms
2
Actual Duration (Days)
304.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Electroretinography
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
May 4, 2022
Actual Primary Completion Date :
May 6, 2022
Actual Study Completion Date :
May 6, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

Diagnostic Test: 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).
Other Names:
  • Electrode Arrays

    		•
    Other: 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.

    Diagnostic Test: 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).
    Other Names:
  • Electrode Arrays

    		•
    Other: 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.

    Diagnostic Test: 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).
    Other Names:
  • Electrode Arrays

    		•

    Outcome Measures

    Primary Outcome Measures

    1. PhNR Latency (ms) [Day 1]

      Change in ERG PhNR Latency (ms) parameter

    Secondary Outcome Measures

    1. FL Latency (ms) [Day 1]

      Change in ERG FL Latency (ms) parameter

    Other Outcome Measures

    1. PhNR B-wave Latency (ms) [Day 1]

      Change in ERG PhNR B-wave Latency (ms) parameter

    2. FL Magnitude (µV) [Day 1]

      Change in ERG FL Magnitude (µV) parameter

    3. PhNR A-Wave Latency (ms) [Day 1]

      Change in ERG PhNR A-Wave Latency (ms) parameter

    4. PhNR Ratio [Day 1]

      Change in ERG PhNR Ratio parameter

    5. PhNR amplitude (µV) [Day 1]

      Change in ERG PhNR amplitude (µV) parameter

    6. PhNR B-Wave Amplitude (µV) [Day 1]

      Change in ERG PhNR B-Wave Amplitude (µV) parameter

    7. PhNR A-Wave Amplitude (µV) [Day 1]

      Change in ERG PhNR A-Wave Amplitude (µV) parameter

    8. FL Phase (deg) [Day 1]

      Change in ERG FL Phase (deg) parameter

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NSU Oklahoma College of Optometry Tahlequah Oklahoma United States 74464

    Sponsors and Collaborators

    • Diopsys, Inc.

    Investigators

    • Principal Investigator: Nate Lighthizer, OD, NSU Oklahoma College of Optometry

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Diopsys, Inc.
    ClinicalTrials.gov Identifier:
    NCT05416268
    Other Study ID Numbers:
    • 200
    First Posted:
    Jun 13, 2022
    Last Update Posted:
    Jun 14, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Retinal Diseases

    Study Results

    No Results Posted as of Jun 14, 2022