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CompletedNCT05416268Updated Jun 14, 2022

Study to Compare the Diopsys NOVA and LKC RETeval Devices

An interventional study of Electroretinography in Retinal Disease, sponsored by Diopsys, Inc.. Completed at 1 site in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-14.

Sponsored by Diopsys, Inc. · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was May 2022, 4 years 5 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
22 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Retinal Disease

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03

In context

Retinal Diseases

815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.

This study's enrollment of 20 is below the median of 60 across 500 interventional studies indexed under Retinal Diseases.

Browse Retinal Diseases studies →

Lead sponsor

Diopsys, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • Diagnostic testElectroretinography

    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

06

What researchers measure

Primary outcomes

  1. PhNR Latency (ms)

    Change in ERG PhNR Latency (ms) parameter

    Time frame: Day 1

Secondary outcomes

  1. FL Latency (ms)

    Change in ERG FL Latency (ms) parameter

    Time frame: Day 1

Other outcomes

  1. PhNR B-wave Latency (ms)

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

    Time frame: Day 1

  2. FL Magnitude (µV)

    Change in ERG FL Magnitude (µV) parameter

    Time frame: Day 1

  3. PhNR A-Wave Latency (ms)

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

    Time frame: Day 1

  4. PhNR Ratio

    Change in ERG PhNR Ratio parameter

    Time frame: Day 1

  5. PhNR amplitude (µV)

    Change in ERG PhNR amplitude (µV) parameter

    Time frame: Day 1

  6. PhNR B-Wave Amplitude (µV)

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

    Time frame: Day 1

  7. PhNR A-Wave Amplitude (µV)

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

    Time frame: Day 1

  8. FL Phase (deg)

    Change in ERG FL Phase (deg) parameter

    Time frame: Day 1

07

Study locations

1 site
  • NSU Oklahoma College of Optometry
    Tahlequah, Oklahoma 74464, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05416268
Lead sponsor
Diopsys, Inc.
Responsible party
Sponsor
First posted
Jun 13, 2022
Start date
May 4, 2022
Primary completion
May 6, 2022
Completion
May 6, 2022
Last update
Jun 14, 2022

Study contacts

Nate Lighthizer, OD
principal investigator · NSU Oklahoma College of Optometry

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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