Normative Database for Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG) (DIOPSYS-ND)
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|ClinicalTrials.gov Identifier: NCT02609204|
Recruitment Status : Completed
First Posted : November 20, 2015
Results First Posted : September 17, 2018
Last Update Posted : December 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Diagnostic Test: Diopsys NOVA||Not Applicable|
Investigators plan to enroll 50 subjects at Wills Eye Hospital without any eye diseases.
Participants will undergo a complete eye examination to determine eligibility, including visual acuity testing, intraocular pressure (IOP) in millimeters of mercury (mmHG), and visual field (VF) testing.
Participants will then be tested with Diopsys NOVA™ PERG & FERG systems. For both tests, two electrodes are placed on the skin underneath each eye below the eyelashes. Participants' skin will be cleaned before electrodes are placed. A small amount of gel will be placed on skin where electrodes are placed for testing. Electrical responses are recorded with electrodes in response to visual stimuli.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||NOVA™ PERG (Pattern Electroretinogram)and FERG (Flash Electroretinogram): Establishment of Reference Values for PERG and FERG Measurements|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
Experimental: Healthy Controls
Participants with normal eye exams and no history of eye diseases will best tested with Diopsys NOVA.
Diagnostic Test: Diopsys NOVA
Healthy Controls will have both eyes tested by the Diopsys NOVA machine using Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG) modules.
Other Name: Diopsys-ND
- Flash Electroretinogram (FERG) Module Using Diopsys NOVA (Neuro Optic Vision Assessment) Amplitude [ Time Frame: 2 hours ]Clinical data from participants with a normal eye examination to establish expected normal values of Flash Electroretinogram (FERG) photopic negative response (PhNR) amplitude in micro volts.
- Flash Electroretinogram (FERG) Module Using Diopsys NOVA Latency [ Time Frame: 2 hours ]Clinical data from participants with a normal eye examination to establish expected normal values of Flash Electroretinogram (FERG) photopic negative response (PhNR) latency in milliseconds.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609204
|United States, Pennsylvania|
|Wills Eye Hospital|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||L. Jay Katz, MD||Wills Eye Hospital|