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RETeval All Comers Trial (REACT) (REACT)

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ClinicalTrials.gov Identifier: NCT03065881
Recruitment Status : Unknown
Verified February 2017 by LKC Technologies, Inc..
Recruitment status was:  Recruiting
First Posted : February 28, 2017
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
LKC Technologies, Inc.

Brief Summary:
The primary objective of this study is to collect electroretinogram ERG measurements from visually normal and abnormal subjects using the FDA cleared RETeval device (K142567). Data from the visually normal subjects will be used to create reference intervals for the device. Secondary objectives of the study are to provide ERG waveforms representative of disease states encountered and to analyze how well an ERG detects the various disease states encountered.

Condition or disease Intervention/treatment Phase
Retinal Disease, Electroretinogram Device: RETeval Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: RETeval All Comers Trial (REACT)
Actual Study Start Date : February 13, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dilated versus Natural pupil Device: RETeval
The RETeval device measures the retina's electrical response to light, called an electroretinogram (ERG). The standards body ISCEV [1] recommends collecting normative data for ERGs to provide waveforms and statistically relevant measurements representing the range of ERGs from people with normal vision. LKC Technologies provides this information with their UTAS product line and wishes to collect such a database for the newest device: the RETeval device. As the RETeval device uses a different electrode to measure the ERG, the normal data for the UTAS product line is not transferable to the RETeval device. Ophthalmic practitioners would also like ERG examples of specific retinal disorders to help diagnose patients with abnormal ERGs. The RETeval device is FDA cleared (K142567),

Active Comparator: Normal retina versus abnormal retina Device: RETeval
The RETeval device measures the retina's electrical response to light, called an electroretinogram (ERG). The standards body ISCEV [1] recommends collecting normative data for ERGs to provide waveforms and statistically relevant measurements representing the range of ERGs from people with normal vision. LKC Technologies provides this information with their UTAS product line and wishes to collect such a database for the newest device: the RETeval device. As the RETeval device uses a different electrode to measure the ERG, the normal data for the UTAS product line is not transferable to the RETeval device. Ophthalmic practitioners would also like ERG examples of specific retinal disorders to help diagnose patients with abnormal ERGs. The RETeval device is FDA cleared (K142567),




Primary Outcome Measures :
  1. Retinal function assessed with an electroretinogram (ERG) [ Time Frame: 1 year ]
    Response of the retina exposed to the flashes of light. ERG describes retinal function.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 95 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All volunteers (age 0.5 to 95) willing to participate in the study as a part of their routine eye exam.
  • While not specifically targeting vulnerable groups such as for example children and pregnant women, we invite them to participate in the study. Collecting normative data from these less represented populations is particularly difficult and we welcome the opportunity to gather these rare data.
  • Subjects under the age of 18 will be included with the assent of the subject (for those at least 10 years of age) and consent from one parent/guardian (for those under age of 10).
  • In any case patient is not able to provide the consent by him/her self and is willing to participate in the study the same person that is consenting for the routine eye exam can consent for the REACT study.

Exclusion Criteria:

  • Subjects with photosensitive epilepsy , allergies to pupil dilating agents, or history of cardiac dysrhythmia will not be invited to participate in this study. - Subjects with history of glaucoma can either be included in the group of non dilated subjects or can have dilated ERGs if the dilation was recommended by the health professional as the part of the routine eye exam.
  • Exclusion criteria will be based on volunteer's providing this information at the time of signing the consent form.
  • If patient is not aware of his photosensitive epilepsy and it occurs during the recording, the test will be interrupted immediately.
  • Statistically, 1 person out of 3600 people can suffer from photosensitive epilepsy in US.
  • There is a rather small possibility we will encounter such a person during the collection of ERGs from the group of 1000 volunteers

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): NCT03065881


Contacts
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Contact: Olga Kraszewska, PhD olgakraszewska.phd@gmail.com

Locations
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United States, New York
Brooklyn Eye Center Recruiting
Brooklyn, New York, United States, 11216
Contact: Olga Kraszewska, Ph.D.    682-551-2601    olgakraszewska.phd@gmail.com   
Sponsors and Collaborators
LKC Technologies, Inc.

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Responsible Party: LKC Technologies, Inc.
ClinicalTrials.gov Identifier: NCT03065881     History of Changes
Other Study ID Numbers: LKC-2017-1
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: February 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Retinal Diseases
Eye Diseases