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Study of Stimulus Parameters in Flicker Electroretinogram (ERG)

Primary Purpose

Retinopathy

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RETeval color flicker ERG
RETeval dilated versus un-dilated flicker ERG
pupil dilation
Sponsored by
LKC Technologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Retinopathy focused on measuring Retinal function

Eligibility Criteria

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

Inclusion Criteria:

  • healthy adult volunteers
  • volunteers able to get their pupil fully dilated

Exclusion Criteria:

  • pregnant women
  • children
  • subjects with
  • light sensitivity
  • photosensitive epilepsy
  • allergies or sensitivity to pupil dilation ophthalmic solutions
  • history of glaucoma
  • cardiac dysrhythmia will not be invited to participate in this study.
  • Pregnancy status, light sensitivity and photosensitive epilepsy will be based on volunteer's providing this information at the time of signing the consent form

Sites / Locations

  • Wedgwood OptometryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

RETeval color flicker ERG

RETeval dilated versus un-dilated flicker ERG

Arm Description

Compare implicit times and amplitudes of electroretinograms obtained from series of color flashes to those obtained from white flashes.

Compare implicit times and amplitudes of ERGs obtained from cd/m2/sec stimulation (used with dilated pupils) to those obtained from troland stimulation (used with un-dilated pupils).

Outcomes

Primary Outcome Measures

Flicker harmonic amplitude
Flicker harmonic implicit time
Flicker fundamental amplitude
Flicker fundamental implicit time

Secondary Outcome Measures

Full Information

First Posted
June 3, 2015
Last Updated
June 8, 2015
Sponsor
LKC Technologies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02466607
Brief Title
Study of Stimulus Parameters in Flicker Electroretinogram (ERG)
Official Title
Study of Stimulus Parameters in Flicker Electroretinogram (ERG)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LKC Technologies, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The electroretinogram (ERG) is a diagnostic test that measures the electrical activity generated by cells in the retina in response to a light stimulus. Typically, an ERG is recorded with white flash when the pupil is dilated. RETeval Visual Diagnostic Device (RETeval) generates an array of color flashes, which allows studying whether color flash would be a useful diagnostic tool. Full pupil dilation is required to obtain a response from the whole retina. However, this requirement often limits a patient's flow in the clinic and increases the overall time patients spend at the eye practitioner. RETeval provides the possibility of recording ERGs in un-dilated pupils therefore making the whole exam easier and shorter. These results need to be compared to the classic, fully dilated ERG and evaluated for efficiency. The purpose of this research study is to use the RETeval device to measure the eye's electrical response and how it changes with different stimuli such as changing flash color or pupil dilation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinopathy
Keywords
Retinal function

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RETeval color flicker ERG
Arm Type
Other
Arm Description
Compare implicit times and amplitudes of electroretinograms obtained from series of color flashes to those obtained from white flashes.
Arm Title
RETeval dilated versus un-dilated flicker ERG
Arm Type
Other
Arm Description
Compare implicit times and amplitudes of ERGs obtained from cd/m2/sec stimulation (used with dilated pupils) to those obtained from troland stimulation (used with un-dilated pupils).
Intervention Type
Device
Intervention Name(s)
RETeval color flicker ERG
Intervention Description
Flicker ERGs obtained to 56 CIE 1931 (created by the International Commission on Illumination (CIE) in 1931) colors series. White flash of 0,33, 0,33 was used for comparison.
Intervention Type
Device
Intervention Name(s)
RETeval dilated versus un-dilated flicker ERG
Intervention Description
Two series of white flashes: 3,0 cd/m2/sec and Trolands equivalent assuming 3,7 mm pupil size, delivered at 3 min interval over 30 min.
Intervention Type
Other
Intervention Name(s)
pupil dilation
Intervention Description
Pupil will be dilated using Proparacaine 0.5% and Tropicamide 0.5%
Primary Outcome Measure Information:
Title
Flicker harmonic amplitude
Time Frame
up to 2 mnths
Title
Flicker harmonic implicit time
Time Frame
up to 2 months
Title
Flicker fundamental amplitude
Time Frame
up to 2 months
Title
Flicker fundamental implicit time
Time Frame
up to 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy adult volunteers volunteers able to get their pupil fully dilated Exclusion Criteria: pregnant women children subjects with light sensitivity photosensitive epilepsy allergies or sensitivity to pupil dilation ophthalmic solutions history of glaucoma cardiac dysrhythmia will not be invited to participate in this study. Pregnancy status, light sensitivity and photosensitive epilepsy will be based on volunteer's providing this information at the time of signing the consent form
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olga Kraszewska, Ph.D.
Phone
682-551-2601
Email
olgakraszewska.phd@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olga Kraszewska, Ph.D.
Organizational Affiliation
LKC Technologies
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wedgwood Optometry
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76133
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olga Kraszewska, Ph.D.
Phone
682-551-2601
Email
olgakraszewska.phd@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
28160194
Citation
Davis CQ, Kraszewska O, Manning C. Constant luminance (cd.s/m2) versus constant retinal illuminance (Td.s) stimulation in flicker ERGs. Doc Ophthalmol. 2017 Apr;134(2):75-87. doi: 10.1007/s10633-017-9572-3. Epub 2017 Feb 3.
Results Reference
derived

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Study of Stimulus Parameters in Flicker Electroretinogram (ERG)

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