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Completed

NCT Number: NCT05416268

Study to Compare the Diopsys NOVA and LKC RETeval Devices

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

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NSU Oklahoma College of Optometry

Tahlequah, Oklahoma, 74464, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: Electrode Arrays

Primary outcomes

  1. PhNR Latency (ms)

    Time frame: Day 1

    Change in ERG PhNR Latency (ms) parameter

Secondary outcomes

  1. FL Latency (ms)

    Time frame: Day 1

    Change in ERG FL Latency (ms) parameter

Other outcomes

  1. PhNR B-wave Latency (ms)

    Time frame: Day 1

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

  2. FL Magnitude (µV)

    Time frame: Day 1

    Change in ERG FL Magnitude (µV) parameter

  3. PhNR A-Wave Latency (ms)

    Time frame: Day 1

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

  4. PhNR Ratio

    Time frame: Day 1

    Change in ERG PhNR Ratio parameter

  5. PhNR amplitude (µV)

    Time frame: Day 1

    Change in ERG PhNR amplitude (µV) parameter

  6. PhNR B-Wave Amplitude (µV)

    Time frame: Day 1

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

  7. PhNR A-Wave Amplitude (µV)

    Time frame: Day 1

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

  8. FL Phase (deg)

    Time frame: Day 1

    Change in ERG FL Phase (deg) parameter

Sponsors and collaborators

Lead sponsor

Diopsys, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 13, 2022
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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