NCT02609204

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

September 17, 2018

Completed
Last Updated

December 4, 2018

Status Verified

November 1, 2018

Enrollment Period

1.3 years

First QC Date

August 7, 2015

Results QC Date

December 21, 2017

Last Update Submit

November 7, 2018

Conditions

Glaucoma

Keywords

Pattern Electroretinogram (PERG)Flash Electroretinogram (FERG)

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Healthy Controls

EXPERIMENTAL

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

Diagnostic Test: Diopsys NOVA

Interventions

Diopsys NOVADIAGNOSTIC_TEST

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

Also known as: Diopsys-ND
Healthy Controls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers age 18 years
  • older with normal eye exam

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Limitations and Caveats

All participants came from the same location.

Results Point of Contact

Title
Dr. L. Jay Katz
Organization
Wills Eye Hospital, Glaucoma Research Center
ljkatz@willseye.org
215-928-3123

Study Officials

  • L. Jay Katz, MD

    Wills Eye Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Glaucoma Specialist

Study Record Dates

First Submitted

August 7, 2015

First Posted

November 20, 2015

Study Start

November 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

December 4, 2018

Results First Posted

September 17, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)