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Study to Compare the Diopsys NOVA and LKC RETeval Devices

Primary Purpose

Retinal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electroretinography
Sponsored by
Diopsys, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Retinal Disease

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • NSU Oklahoma College of Optometry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Diopsys NOVA and Diopsys Electrodes

Diopsys device with LKC Electrode Arrays

LKC device with the LKC electrode arrays

Arm Description

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.

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 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.

Outcomes

Primary Outcome Measures

PhNR Latency (ms)
Change in ERG PhNR Latency (ms) parameter

Secondary Outcome Measures

FL Latency (ms)
Change in ERG FL Latency (ms) parameter

Full Information

First Posted
June 1, 2022
Last Updated
June 10, 2022
Sponsor
Diopsys, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05416268
Brief Title
Study to Compare the Diopsys NOVA and LKC RETeval Devices
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
May 4, 2022 (Actual)
Primary Completion Date
May 6, 2022 (Actual)
Study Completion Date
May 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Diopsys, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diopsys NOVA and Diopsys Electrodes
Arm Type
Other
Arm Description
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.
Arm Title
Diopsys device with LKC Electrode Arrays
Arm Type
Other
Arm Description
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.
Arm Title
LKC device with the LKC electrode arrays
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Electroretinography
Other Intervention Name(s)
Electrode Arrays
Intervention Description
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).
Primary Outcome Measure Information:
Title
PhNR Latency (ms)
Description
Change in ERG PhNR Latency (ms) parameter
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
FL Latency (ms)
Description
Change in ERG FL Latency (ms) parameter
Time Frame
Day 1
Other Pre-specified Outcome Measures:
Title
PhNR B-wave Latency (ms)
Description
Change in ERG PhNR B-wave Latency (ms) parameter
Time Frame
Day 1
Title
FL Magnitude (µV)
Description
Change in ERG FL Magnitude (µV) parameter
Time Frame
Day 1
Title
PhNR A-Wave Latency (ms)
Description
Change in ERG PhNR A-Wave Latency (ms) parameter
Time Frame
Day 1
Title
PhNR Ratio
Description
Change in ERG PhNR Ratio parameter
Time Frame
Day 1
Title
PhNR amplitude (µV)
Description
Change in ERG PhNR amplitude (µV) parameter
Time Frame
Day 1
Title
PhNR B-Wave Amplitude (µV)
Description
Change in ERG PhNR B-Wave Amplitude (µV) parameter
Time Frame
Day 1
Title
PhNR A-Wave Amplitude (µV)
Description
Change in ERG PhNR A-Wave Amplitude (µV) parameter
Time Frame
Day 1
Title
FL Phase (deg)
Description
Change in ERG FL Phase (deg) parameter
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nate Lighthizer, OD
Organizational Affiliation
NSU Oklahoma College of Optometry
Official's Role
Principal Investigator
Facility Information:
Facility Name
NSU Oklahoma College of Optometry
City
Tahlequah
State/Province
Oklahoma
ZIP/Postal Code
74464
Country
United States

12. IPD Sharing Statement

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Study to Compare the Diopsys NOVA and LKC RETeval Devices

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