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Study of Stimulus Parameters in Flicker Electroretinogram (ERG)

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ClinicalTrials.gov Identifier: NCT02466607
Recruitment Status : Unknown
Verified June 2015 by LKC Technologies, Inc..
Recruitment status was:  Recruiting
First Posted : June 9, 2015
Last Update Posted : June 9, 2015
Sponsor:
Information provided by (Responsible Party):
LKC Technologies, Inc.

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.


Condition or disease Intervention/treatment Phase
Retinopathy Device: RETeval color flicker ERG Device: RETeval dilated versus un-dilated flicker ERG Other: pupil dilation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study of Stimulus Parameters in Flicker Electroretinogram (ERG)
Study Start Date : March 2015
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Arm Intervention/treatment
RETeval color flicker ERG
Compare implicit times and amplitudes of electroretinograms obtained from series of color flashes to those obtained from white flashes.
Device: RETeval color flicker ERG
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.

RETeval dilated versus un-dilated flicker ERG
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).
Device: RETeval dilated versus un-dilated flicker ERG
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.

Other: pupil dilation
Pupil will be dilated using Proparacaine 0.5% and Tropicamide 0.5%




Primary Outcome Measures :
  1. Flicker harmonic amplitude [ Time Frame: up to 2 mnths ]
  2. Flicker harmonic implicit time [ Time Frame: up to 2 months ]
  3. Flicker fundamental amplitude [ Time Frame: up to 2 months ]
  4. Flicker fundamental implicit time [ Time Frame: up to 2 months ]


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 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

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): NCT02466607


Contacts
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Contact: Olga Kraszewska, Ph.D. 682-551-2601 olgakraszewska.phd@gmail.com

Locations
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United States, Texas
Wedgwood Optometry Recruiting
Fort Worth, Texas, United States, 76133
Contact: Olga Kraszewska, Ph.D.    682-551-2601    olgakraszewska.phd@gmail.com   
Sponsors and Collaborators
LKC Technologies, Inc.
Investigators
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Principal Investigator: Olga Kraszewska, Ph.D. LKC Technologies

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: LKC Technologies, Inc.
ClinicalTrials.gov Identifier: NCT02466607     History of Changes
Other Study ID Numbers: SAIRB-15-0017
First Posted: June 9, 2015    Key Record Dates
Last Update Posted: June 9, 2015
Last Verified: June 2015

Keywords provided by LKC Technologies, Inc.:
Retinal function