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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
Sponsor:
Information provided by (Responsible Party):
L. Jay Katz MD, Wills Eye

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.

Condition or disease Intervention/treatment Phase
Glaucoma Diagnostic Test: Diopsys NOVA Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
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




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Locations
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United States, Pennsylvania
Wills Eye Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wills Eye
Investigators
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Principal Investigator: L. Jay Katz, MD Wills Eye Hospital

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Responsible Party: L. Jay Katz MD, Glaucoma Specialist, Wills Eye
ClinicalTrials.gov Identifier: NCT02609204    
Other Study ID Numbers: 14-426E
First Posted: November 20, 2015    Key Record Dates
Results First Posted: September 17, 2018
Last Update Posted: December 4, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by L. Jay Katz MD, Wills Eye:
Pattern Electroretinogram (PERG)
Flash Electroretinogram (FERG)
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases