Study to Compare the Diopsys NOVA and LKC RETeval Devices

Retinal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05416268
• Other study ID #: 200
• Status: Completed
• Phase: N/A
• Start date: May 4, 2022
• Est. completion date: May 6, 2022

Study information

• Verified date: June 2022
• Source: Diopsys, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 6, 2022
• Est. primary completion date: May 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Retinal Disease
• Retinal Diseases

Intervention

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).

Locations

Country	Name	City	State
United States	NSU Oklahoma College of Optometry	Tahlequah	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Diopsys, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PhNR B-wave Latency (ms)	Change in ERG PhNR B-wave Latency (ms) parameter	Day 1
Other	FL Magnitude (µV)	Change in ERG FL Magnitude (µV) parameter	Day 1
Other	PhNR A-Wave Latency (ms)	Change in ERG PhNR A-Wave Latency (ms) parameter	Day 1
Other	PhNR Ratio	Change in ERG PhNR Ratio parameter	Day 1
Other	PhNR amplitude (µV)	Change in ERG PhNR amplitude (µV) parameter	Day 1
Other	PhNR B-Wave Amplitude (µV)	Change in ERG PhNR B-Wave Amplitude (µV) parameter	Day 1
Other	PhNR A-Wave Amplitude (µV)	Change in ERG PhNR A-Wave Amplitude (µV) parameter	Day 1
Other	FL Phase (deg)	Change in ERG FL Phase (deg) parameter	Day 1
Primary	PhNR Latency (ms)	Change in ERG PhNR Latency (ms) parameter	Day 1
Secondary	FL Latency (ms)	Change in ERG FL Latency (ms) parameter	Day 1