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

NCT ID: NCT02609204

Last Updated: 2018-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-02-29

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.

Conditions

Glaucoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Healthy Controls

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

Group Type: EXPERIMENTAL

Diopsys NOVA

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Diopsys NOVA

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Diopsys-ND

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wills Eye

OTHER

Sponsor Role: lead

Responsible Party

L. Jay Katz MD

Glaucoma Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

L. Jay Katz, MD

Role: PRINCIPAL_INVESTIGATOR

Wills Eye Hospital

Locations

Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

14-426E

Identifier Type: -

Identifier Source: org_study_id