Electrode Site ReactionEarly Phase 1NCT05509608
Evaluating a New Sensor That Measures the Health of the Retina in Normally-sighted Subjects
A Early Phase 1 study testing RM Electrode and ERG Jet Electrode in people with Electrode Site Reaction, run by RetMap, Inc at 2 sites in United States.
Trial summary
The primary purpose of this study is to evaluate the ability of a new contact lens electrode to record a measurable electroretinogram (ERG). ERG sensors in various forms have been in common clinical use for more than 50 years. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Electrode Site Reaction
- What is being tested?
- RM Electrode and ERG Jet Electrode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2023to 31 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- Persons 18 and over.
Who cannot join
- Pregnant woman
- Individuals with existing diagnosis for any retinal disease, ocular surgery (including refractive surgery such as Lasik) within the past six months, corneal ulcers, or any noticeable ocular irritation on the study day.
- Non-English speaking persons may not enroll.
- Persons who may respond negatively to flashing lights in the eye will be excluded, or excused from the study if enrolled and the negative response is revealed during the study.
- Excluded or Vulnerable Populations:
- No vulnerable populations are expected to enroll.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UIC Department of Ophthalmology & Visual Sciences
Chicago, Illinois, 60612
Illinois College of Optometry
Chicago, Illinois, 60616
About this study
Official title: Evaluation of an Electroretinogram Sensor
The primary purpose of this study is to evaluate the ability of a new contact lens electrode to record a measurable electroretinogram (ERG). ERG sensors in various forms have been in common clinical use for more than 50 years. The ERG sensor that is the subject of this study is the RM Electrode, developed by RetMap, Inc. (project sponsor). The RM Electrode is not yet approved by the FDA. The RM Electrode will be compared to other commercially available electrode
The first Aim of the present study is to compare the functionality of the RM Electrode and other commercially available electrodes. Following standard ERG test protocols, responses will be recorded from ten healthy (normally-sighted) adult subjects using both electrodes (used in random order). The signal quality of the ERG responses obtained from both contact lens electrodes will be compared. Signal quality will be determined by measuring ERG signal amplitudes and calculating signal-to-noise ratios (SNR). Signal-to-noise ratios will be used to establish substantial equivalence. ERG test results will not be used to determine the effect of the devices on the participants.
The second Aim of the present study is to evaluate the risk of ocular irritation caused by use of the RM Electrode compared to other commercially available electrodes. A typical ERG test session lasts 20 minutes. Ten healthy (normally-sighted) adult subjects will wear the RM Electrode on one eye and a commercially available electrode on the other eye, for a total of 60 minutes, in 20-minute sessions with short breaks in between. To determine the effect of the devices on the participants, the eyes will be evaluated for irritation.
- Conditions
- Electrode Site Reaction
- Being tested
- RM Electrode, ERG Jet Electrode
- Keywords
- Electroretinogram, Sensor, Retina, Contact lens, Electrode, Efficacy, Feasibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RM ElectrodeDevice
The RM Electrode is a corneal ERG electrode. The distinguishing features of the RM electrode are that it is a soft contact lens with a recessed electrode (i.e. no metal electrode makes direct contact with the eye). The RM Electrode also has an integral speculum to hold the wearer's eye lids open. The electrode is designed for superior positional stability on the eye during testing. These features work together to improve ERG signal quality.
ERG Jet ElectrodeDevice
The ERG Jet electrode is an FDA approved, commercially available corneal ERG electrode.
| Study group | Role | What they receive |
|---|---|---|
| Electroretinogram Signal Quality | Experimental | Electroretinogram Signal Quality: This Arm will participate in a comparative study using two ERG sensors, one commercially available electrode and one seeking FDA approval (RM Electrode). This will be done by performing standard ERG test protocols with both electrodes worn one at a time, in one eye (random order) in ten healthy (normally-sighted) adult subjects. Receives: Device: RM Electrode; Device: ERG Jet Electrode |
| Ocular Irritation | Experimental | Ocular Irritation: Ten healthy (normally-sighted) adult subjects will wear the RM Electrode in one eye and a commercially available electrode in the other eye for a total of 60 minutes, in 20-minute sessions with short breaks in between. The eyes will be evaluated for irritation (standard clinical grading scales for bulbar redness, limbal redness, tarsal redness, and slit-lamp examination of corneal staining) after each 20-minute interval. Receives: Device: RM Electrode; Device: ERG Jet Electrode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm1: ERG signal quality, including peak amplitudes, noise levels, and signal to noise ratios.
Signals recorded from both contact lens electrode will be evaluated for a-wave and b-wave peak amplitudes, signal power, noise power and signal-to-noise ratios.
Measured: Up to 24 weeks
Arm 2: Ocular irritation using clinical grading scales
Slit-lamp examination and standard clinical grading scales for bulbar redness, limbal redness, tarsal redness, and corneal staining (fluorescein).
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Mar 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Electrode Site ReactionStudies 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This study is structured with two Arms (Aims). For the first Arm (Aim 1) of this study, subjects (n=10) wear two ERG sensors, a new contact lens electrode and an FDA approved contact lens electrode, one after the other. The signal quality of the recorded ERG responses obtained with each sensor will be compared. Comparison of signal quality will help in assessing the functionality of the new contact lens electrode. For the second Arm (Aim 2) of this study, subjects (n=10) will wear the two ERG sensors at the same time, one in each eye. After 20, 40 and 60 minutes of wear, each eye will be examined for irritation using standard clinical scales. Observing for ocular irritation will help determine the effect of the devices on the participants.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RetMap, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Illinois Chicago, Illinois College of Optometry
- Responsible party
- Sponsor
- Investigators
- Robert Hyde, MD/PhD, Principal investigator, UIC Department of Ophthalmology & Visual SciencesMichael Chaglasian, OD, Principal investigator, Illinois College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509608
- Sponsor's protocol ID
- RMEFDA2022
- Status last verified
- Aug 2026
- First submitted
- 14 Jul 2022
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
McCulloch DL, Marmor MF, Brigell MG, Hamilton R, Holder GE, Tzekov R, Bach M. ISCEV Standard for full-field clinical electroretinography (2015 update). Doc Ophthalmol. 2015 Feb;130(1):1-12. doi: 10.1007/s10633-014-9473-7. Epub 2014 Dec 14.
PubMed 25502644Hoffmann MB, Bach M, Kondo M, Li S, Walker S, Holopigian K, Viswanathan S, Robson AG. ISCEV standard for clinical multifocal electroretinography (mfERG) (2021 update). Doc Ophthalmol. 2021 Feb;142(1):5-16. doi: 10.1007/s10633-020-09812-w. Epub 2021 Jan 25.
PubMed 33492495
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Electroretinogram Sensor
- ClinicalTrials.gov ID
- NCT05509608
- Acronym / sponsor ID
- RMEFDA2022
- Conditions
- Electrode Site Reaction
- Keywords
- Electroretinogram, Sensor, Retina, Contact lens, Electrode, Efficacy, Feasibility
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- RetMap, IncIndustry (pharma, biotech, devices)
- Collaborators
- University of Illinois Chicago, Illinois College of Optometry
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Aug 2022 (actual)
- 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 primary purpose of this study is to evaluate the ability of a new contact lens electrode to record a measurable electroretinogram (ERG). ERG sensors in various forms have been in common clinical use for more than 50 years. The ERG sensor that is the subject of this study is the RM Electrode, developed by RetMap, Inc. (project sponsor). The RM Electrode is not yet approved by the FDA. The RM Electrode will be compared to other commercially available electrode
The first Aim of the present study is to compare the functionality of the RM Electrode and other commercially available electrodes. Following standard ERG test protocols, responses will be recorded from ten healthy (normally-sighted) adult subjects using both electrodes (used in random order). The signal quality of the ERG responses obtained from both contact lens electrodes will be compared. Signal quality will be determined by measuring ERG signal amplitudes and calculating signal-to-noise ratios (SNR). Signal-to-noise ratios will be used to establish substantial equivalence. ERG test results will not be used to determine the effect of the devices on the participants.
The second Aim of the present study is to evaluate the risk of ocular irritation caused by use of the RM Electrode compared to other commercially available electrodes. A typical ERG test session lasts 20 minutes. Ten healthy (normally-sighted) adult subjects will wear the RM Electrode on one eye and a commercially available electrode on the other eye, for a total of 60 minutes, in 20-minute sessions with short breaks in between. To determine the effect of the devices on the participants, the eyes will be evaluated for irritation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is structured with two Arms (Aims). For the first Arm (Aim 1) of this study, subjects (n=10) wear two ERG sensors, a new contact lens electrode and an FDA approved contact lens electrode, one after the other. The signal quality of the recorded ERG responses obtained with each sensor will be compared. Comparison of signal quality will help in assessing the functionality of the new contact lens electrode. For the second Arm (Aim 2) of this study, subjects (n=10) will wear the two ERG sensors at the same time, one in each eye. After 20, 40 and 60 minutes of wear, each eye will be examined for irritation using standard clinical scales. Observing for ocular irritation will help determine the effect of the devices on the participants.
| Arm | Type | Receives |
|---|---|---|
| Electroretinogram Signal Quality | Experimental | Device: RM Electrode, Device: ERG Jet ElectrodeElectroretinogram Signal Quality: This Arm will participate in a comparative study using two ERG sensors, one commercially available electrode and one seeking FDA approval (RM Electrode). This will be done by performing standard ERG test protocols with both electrodes worn one at a time, in one eye (random order) in ten healthy (normally-sighted) adult subjects. |
| Ocular Irritation | Experimental | Device: RM Electrode, Device: ERG Jet ElectrodeOcular Irritation: Ten healthy (normally-sighted) adult subjects will wear the RM Electrode in one eye and a commercially available electrode in the other eye for a total of 60 minutes, in 20-minute sessions with short breaks in between. The eyes will be evaluated for irritation (standard clinical grading scales for bulbar redness, limbal redness, tarsal redness, and slit-lamp examination of corneal staining) after each 20-minute interval. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Persons 18 and over.
Key exclusion criteria (6 listed)
- Pregnant woman
- Individuals with existing diagnosis for any retinal disease, ocular surgery (including refractive surgery such as Lasik) within the past six months, corneal ulcers, or any noticeable ocular irritation on the study day.
- Non-English speaking persons may not enroll.
- Persons who may respond negatively to flashing lights in the eye will be excluded, or excused from the study if enrolled and the negative response is revealed during the study.
- No vulnerable populations are expected to enroll.
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 |
|---|---|---|
| RM ElectrodeThe RM Electrode is a corneal ERG electrode. The distinguishing features of the RM electrode are that it is a soft contact lens with a recessed electrode (i.e. no metal electrode makes direct contact with the eye). The RM Electrode also has an integral speculum to hold the wearer's eye lids open. The electrode is designed for superior positional stability on the eye during testing. These features work together to improve ERG signal quality. | Device | Electroretinogram Signal Quality, Ocular Irritation |
| ERG Jet ElectrodeThe ERG Jet electrode is an FDA approved, commercially available corneal ERG electrode. | Device | Electroretinogram Signal Quality, Ocular Irritation |
Primary outcome
Arm1: ERG signal quality, including peak amplitudes, noise levels, and signal to noise ratios.
Time frame: Up to 24 weeks
Signals recorded from both contact lens electrode will be evaluated for a-wave and b-wave peak amplitudes, signal power, noise power and signal-to-noise ratios.
Arm 2: Ocular irritation using clinical grading scales
Time frame: Up to 24 weeks
Slit-lamp examination and standard clinical grading scales for bulbar redness, limbal redness, tarsal redness, and corneal staining (fluorescein).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 25502644McCulloch DL, Marmor MF, Brigell MG, Hamilton R, Holder GE, Tzekov R, Bach M. ISCEV Standard for full-field clinical electroretinography (2015 update). Doc Ophthalmol. 2015 Feb;130(1):1-12. doi: 10.1007/s10633-014-9473-7. Epub 2014 Dec 14.
- Background: PubMed 33492495Hoffmann MB, Bach M, Kondo M, Li S, Walker S, Holopigian K, Viswanathan S, Robson AG. ISCEV standard for clinical multifocal electroretinography (mfERG) (2021 update). Doc Ophthalmol. 2021 Feb;142(1):5-16. doi: 10.1007/s10633-020-09812-w. Epub 2021 Jan 25.
- Individual participant dataSharing planned: No
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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.
Robert Hyde, MD/PhD principal investigator
UIC Department of Ophthalmology & Visual Sciences
Michael Chaglasian, OD principal investigator
Illinois College of Optometry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing RM Electrode and ERG Jet Electrode in people with Electrode Site Reaction, run by RetMap, Inc at 2 sites 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 1 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Arm1: ERG signal quality, including peak amplitudes, noise levels, and signal to noise ratios. (time frame: Up to 24 weeks). The study lists 2 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 NCT05509608, which also lists 2 linked publications.
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 12 Aug 2026.