NCT02609204

Normative Database for Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG)

NOVA™ PERG (Pattern Electroretinogram)and FERG (Flash Electroretinogram): Establishment of Reference Values for PERG and FERG Measurements

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Wills Eye · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The main goal of the study is to compile a normative database for the Neuro Optic Vision Assessment (NOVATM) Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG) modules. This normalization intends to be included in a probabilistic analysis protocol to allow NOVATM PERG/FERG users to identify patients with results outside the normal ranges.

Detailed description

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.

Conditions

• Glaucoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2015-11-20
• Last updated: 2018-12-04
• Results posted: 2018-09-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study