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Normative Database for Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG) (DIOPSYS-ND)

Primary Purpose

Glaucoma

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Diopsys NOVA

About this trial

This is an interventional diagnostic trial for Glaucoma focused on measuring Pattern Electroretinogram (PERG), Flash Electroretinogram (FERG)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Wills Eye Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthy Controls

Arm Description

Participants with normal eye exams and no history of eye diseases will best tested with Diopsys NOVA.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02609204

First Posted

August 7, 2015

Last Updated

November 7, 2018

Sponsor

Wills Eye

1. Study Identification

Unique Protocol Identification Number

NCT02609204

Brief Title

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

Acronym

DIOPSYS-ND

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

November 2014 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wills Eye

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

Keywords

Pattern Electroretinogram (PERG), Flash Electroretinogram (FERG)

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Healthy Controls

Arm Type

Experimental

Arm Description

Participants with normal eye exams and no history of eye diseases will best tested with Diopsys NOVA.

Intervention Type

Diagnostic Test

Intervention Name(s)

Diopsys NOVA

Other Intervention Name(s)

Diopsys-ND

Intervention Description

Healthy Controls will have both eyes tested by the Diopsys NOVA machine using Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG) modules.

Primary Outcome Measure Information:

Title

Flash Electroretinogram (FERG) Module Using Diopsys NOVA (Neuro Optic Vision Assessment) Amplitude

Description

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.

Time Frame

2 hours

Title

Flash Electroretinogram (FERG) Module Using Diopsys NOVA Latency

Description

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.

Time Frame

2 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

L. Jay Katz, MD

Organizational Affiliation

Wills Eye Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wills Eye Hospital

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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