Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
664 participants
INTERVENTIONAL
2017-02-13
2021-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Dilated versus Natural pupil
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),
Normal retina versus abnormal retina
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),
Interventions
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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),
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Months
95 Years
ALL
Yes
Sponsors
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LKC Technologies, Inc.
INDUSTRY
Responsible Party
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Locations
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Little Rock Eye Clinic
Little Rock, Arkansas, United States
Countries
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Other Identifiers
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LKC-2017-1
Identifier Type: -
Identifier Source: org_study_id