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Completed

NCT Number: NCT02609204

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diopsys NOVA

Diagnostic Test

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

Other names: Diopsys-ND

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Wills Eye

Other

Registry information

Official study title

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

Acronym: DIOPSYS-ND

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 20, 2015
Registry last updated
Dec 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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