Back to resultsRETeval All Comers Trial (REACT) (REACT)
Primary Purpose
Retinal Disease, Electroretinogram
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RETeval
Sponsored by
About this trial
This is an interventional screening trial for Retinal Disease, Electroretinogram
Eligibility 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
Sites / Locations
- Little Rock Eye Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Dilated versus Natural pupil
Normal retina versus abnormal retina
Arm Description
Outcomes
Primary Outcome Measures
Retinal function assessed with an electroretinogram (ERG)
Response of the retina exposed to the flashes of light. ERG describes retinal function.
Secondary Outcome Measures
Full Information
NCT ID
NCT03065881
First Posted
February 12, 2017
Last Updated
February 26, 2020
Sponsor
LKC Technologies, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03065881
Brief Title
RETeval All Comers Trial (REACT)
Acronym
REACT
Official Title
RETeval All Comers Trial (REACT)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 13, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LKC Technologies, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Disease, Electroretinogram
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dilated versus Natural pupil
Arm Type
Active Comparator
Arm Title
Normal retina versus abnormal retina
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
RETeval
Intervention Description
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 Measure Information:
Title
Retinal function assessed with an electroretinogram (ERG)
Description
Response of the retina exposed to the flashes of light. ERG describes retinal function.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Little Rock Eye Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
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RETeval All Comers Trial (REACT)
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