Status:
COMPLETED
Study to Compare the Diopsys NOVA and LKC RETeval Devices
Lead Sponsor:
Diopsys, Inc.
Conditions:
Retinal Disease
Eligibility:
All Genders
22+ years
Phase:
NA
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 re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05416268
Start Date
May 4 2022
End Date
May 6 2022
Last Update
June 14 2022
Active Locations (1)
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1
NSU Oklahoma College of Optometry
Tahlequah, Oklahoma, United States, 74464