RetinopathyNCT02466607
Study of Stimulus Parameters in Flicker Electroretinogram (ERG)
A study testing RETeval color flicker ERG, RETeval dilated versus un-dilated flicker ERG and pupil dilation in people with Retinopathy, run by LKC Technologies, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinopathy
- What is being tested?
- RETeval color flicker ERG, RETeval dilated versus un-dilated flicker ERG and pupil dilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy adult volunteers
- volunteers able to get their pupil fully dilated
Who cannot join
- pregnant women
- children
- subjects with
- light sensitivity
- photosensitive epilepsy
- allergies or sensitivity to pupil dilation ophthalmic solutions
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Retinopathy
- Being tested
- RETeval color flicker ERG, RETeval dilated versus un-dilated flicker ERG, pupil dilation
- Keywords
- Retinal function
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RETeval color flicker ERGDevice
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 ERGDevice
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.
pupil dilationOther
Pupil will be dilated using Proparacaine 0.5% and Tropicamide 0.5%
| Study group | Role | What they receive |
|---|---|---|
| RETeval color flicker ERG | Other | Compare implicit times and amplitudes of electroretinograms obtained from series of color flashes to those obtained from white flashes. Receives: Device: RETeval color flicker ERG |
| RETeval dilated versus un-dilated flicker ERG | Other | 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). Receives: Device: RETeval dilated versus un-dilated flicker ERG; Other: pupil dilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flicker harmonic amplitude
Measured: up to 2 mnths
Flicker harmonic implicit time
Measured: up to 2 months
Flicker fundamental amplitude
Measured: up to 2 months
Flicker fundamental implicit time
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- LKC Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olga Kraszewska, Ph.D., Principal investigator, LKC Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466607
- Sponsor's protocol ID
- SAIRB-15-0017
- Status last verified
- Dec 2025
- First submitted
- 3 Jun 2015
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28160194
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Stimulus Parameters in Flicker Electroretinogram (ERG)
- ClinicalTrials.gov ID
- NCT02466607
- Acronym / sponsor ID
- SAIRB-15-0017
- Conditions
- Retinopathy
- Keywords
- Retinal function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- LKC Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2015 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 9 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RETeval color flicker ERG | Other | Device: RETeval color flicker ERGCompare implicit times and amplitudes of electroretinograms obtained from series of color flashes to those obtained from white flashes. |
| RETeval dilated versus un-dilated flicker ERG | Other | Device: RETeval dilated versus un-dilated flicker ERG, Other: pupil dilationCompare 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy adult volunteers
- volunteers able to get their pupil fully dilated
Key exclusion criteria (9 listed)
- pregnant women
- children
- subjects with
- light sensitivity
- photosensitive epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RETeval color flicker ERGFlicker 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. | Device | RETeval color flicker ERG |
| RETeval dilated versus un-dilated flicker ERGTwo 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. | Device | RETeval dilated versus un-dilated flicker ERG |
| pupil dilationPupil will be dilated using Proparacaine 0.5% and Tropicamide 0.5% | Other | RETeval dilated versus un-dilated flicker ERG |
Primary outcome
Flicker harmonic amplitude
Time frame: up to 2 mnths
Flicker harmonic implicit time
Time frame: up to 2 months
Flicker fundamental amplitude
Time frame: up to 2 months
Flicker fundamental implicit time
Time frame: up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Derived from this study: PubMed 28160194Davis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga Kraszewska, Ph.D. principal investigator
LKC Technologies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RETeval color flicker ERG, RETeval dilated versus un-dilated flicker ERG and pupil dilation in people with Retinopathy, run by LKC Technologies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flicker harmonic amplitude (time frame: up to 2 mnths). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02466607, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.