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

Glaucoma Clinical Trial

— DIOPSYS-ND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02609204
• Other study ID #: 14-426E
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: February 2016

Study information

• Verified date: November 2018
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy volunteers age 18 years

• older with normal eye exam

Exclusion Criteria:

• spherical refraction outside + 5.0 Diopters and cylinder correction outside + 3.0 Diopters.

• IOP (intraocular pressure) = 22 mm Hg (millimeters of mercury)

• history of any type of glaucoma in either eye.

• Intraocular surgery in study eye (except non-complicated cataract or refractive surgery performed more than 1 year before enrollment).

• Best corrected visual acuity worse than 20/40.

• Evidence of diabetic retinopathy, diabetic macular edema, or other vitreo-retinal disease in either eye.

• Evidence of optic nerve, macula and/or retinal nerve fiber layer abnormality in either eye.

• Evidence of reproducible (false positives, fixation losses and false negatives = 25% with no observable testing artifacts).

• Standard Automatic Perimetry (SAP) abnormality in either eye, defined as Pattern Standard Deviation < 5% level, and/or abnormal Glaucoma Hemifield test result, and/or any other pattern of loss which is consistent with a neurologic and/or ocular disease.

• Current or recent (within the past 30 days) use of an agent (by any administering method) known to affect visual function.

• Inability to obtain reliable PERG/FERG (Pattern Electroretinogram/Flash Electroretinogram) results.

Related Conditions & MeSH terms

• Glaucoma

Intervention

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.

Locations

Country	Name	City	State
United States	Wills Eye Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Wills Eye

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flash Electroretinogram (FERG) Module Using Diopsys NOVA (Neuro Optic Vision Assessment) Amplitude	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.	2 hours
Primary	Flash Electroretinogram (FERG) Module Using Diopsys NOVA Latency	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.	2 hours