Retinal Health Sensor Evaluation for Electrode Site Reaction

Enrolling by invitation at 1 trial location

Overseen By Chief Technology Officer

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: RetMap, Inc

Disqualifiers: Pregnancy, Retinal disease, Ocular surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 40

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new contact lens electrode, the RM Electrode, to determine if it can effectively record eye responses, known as electroretinograms (ERGs), similar to the standard ERG Jet Electrode. Researchers will also assess whether the RM Electrode causes any eye irritation compared to the ERG Jet Electrode. Participants will wear each electrode on separate eyes for short sessions. Ideal participants have normal vision and no recent eye surgeries or issues such as retinal disease or corneal ulcers. As an Early Phase 1 trial, this research aims to understand how the RM Electrode functions in people, offering participants the chance to be among the first to experience this innovative technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing contact lens electrodes, so it's unlikely that your medications would be affected, but you should confirm with the study team.

What prior data suggests that this contact lens electrode is safe for use in recording electroretinograms?

Research shows that both the ERG Jet Electrode and the RM Electrode are designed to be safe for use on the eyes. The ERG Jet Electrode has been used in medical settings for many years without causing significant eye irritation, as previous studies have documented its safety.

The RM Electrode, still under testing, is made from soft, medical-grade silicone to minimize eye irritation. Tests have shown it does not cause significant irritation in people. Additionally, the RM Electrode includes features to enhance comfort, such as preventing blinking during use.

Overall, both electrodes are expected to be safe for the eyes, prioritizing comfort and minimal irritation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to assess eye health using two different electrodes for electroretinograms (ERG). The RM Electrode, which is seeking FDA approval, could offer an alternative to the commercially available ERG Jet Electrode by potentially providing more accurate signal quality or causing less ocular irritation. This trial aims to determine if the RM Electrode can deliver better comfort or performance, which could lead to improved diagnostic techniques for eye conditions.

What evidence suggests that this trial's devices could be effective for recording electroretinograms?

This trial will evaluate two ERG sensors: the RM Electrode and the ERG Jet Electrode. Research has shown that ERG sensors have been used in medical settings for over 50 years. The RM Electrode, one of the sensors tested in this trial, is a new type designed for comfort and to reduce issues like unwanted signal changes from blinking. Previous studies suggest that the RM Electrode provides consistent and repeatable results. The ERG Jet Electrode, the other sensor in this trial, is a well-known device for assessing eye health by measuring electrical activity in the retina. Studies have shown that it consistently delivers reliable results. Both electrodes aim to capture clear signals to effectively assess retinal function. ^{6 7 8 9 10}

Who Is on the Research Team?

Robert Hyde, MD/PhD

Principal Investigator

UIC Department of Ophthalmology & Visual Sciences

Michael Chaglasian, OD

Principal Investigator

Illinois College of Optometry

Are You a Good Fit for This Trial?

This trial is for healthy adults over 18 with normal vision. It's not for those with retinal diseases, recent eye surgery, corneal ulcers, or irritation on the study day. Non-English speakers, people sensitive to flashing lights, and pregnant women are also excluded.

Inclusion Criteria

No vulnerable populations are expected to enroll.

Persons 18 and over

Exclusion Criteria

Non-English speaking persons may not enroll.

You are sensitive to flashing lights that may cause discomfort or harm to your eyes.

You are pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Electroretinogram Signal Quality Testing

Participants undergo ERG testing using both RM Electrode and ERG Jet Electrode to compare signal quality

1 week

Multiple sessions, each lasting 20 minutes

Ocular Irritation Assessment

Participants wear the RM Electrode and ERG Jet Electrode to assess ocular irritation

1 week

Multiple sessions, each lasting 20 minutes

Follow-up

Participants are monitored for any delayed ocular irritation or other effects

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ERG Jet Electrode
• RM Electrode

Trial Overview The study tests a new RM Electrode against an existing ERG Jet Electrode to record retina health via electroretinogram (ERG). Participants will use both electrodes under standard protocols to compare signal quality and check for ocular irritation.

How Is the Trial Designed?

Group I: Ocular Irritation Experimental Treatment 2 Interventions

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.

Group II: Electroretinogram Signal Quality Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

RetMap, Inc

Lead Sponsor

Trials

1

Recruited

90+

Illinois College of Optometry

Collaborator

Trials

8

Recruited

340+

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0278584625000594

Validating skin electrodes: Paving the way for non-invasive ... This study evaluates a cost-effective alternative: a handheld ERG device paired with less invasive self-adhesive skin electrodes, which require minimal ...

2. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2024.1501149/full

Analysis of skin and corneal fiber electrodes for ... Sensor strip skin electrodes appear to be more effective than corneal electrodes in detecting ERG alterations in patients with MDD when using the RETeval® ...

3. withpower.com withpower.com/trial/early-phase-1-electrode-site-reaction-8-2022-25816

Retinal Health Sensor Evaluation for Electrode Site Reaction The primary purpose of this study is to evaluate the ability of a new contact lens electrode to record a measurable electroretinogram (ERG).

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7414618/

Evaluation of Electrical Performance and Properties ... The aim of this study was to evaluate and compare the electrical performance and properties of commercially available electroretinography (ERG) electrodes.

5. nature.com nature.com/articles/s41598-025-17856-8

Longitudinal retinal functional evaluation using full-field ... ERG testing was consistently performed between 9:00 AM and 11:00 AM to reduce variability due to circadian rhythms in retinal function. ERG-Jet ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11781330/

Ocular Safety and Toxicology of Subretinal Gene Therapy ... This study demonstrates that treatment candidate rAAV.PDE6A was well tolerated in NHPs. Occurrence of retinal atrophy as a dose-limiting finding highlights the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12155663/

Electroretinography With the RM Electrode: Normative ... The RM Electrode is a new, single-use, soft-contact lens electrode for recording the full-field electroretinogram (ffERG).

8. sciencedirect.com sciencedirect.com/science/article/pii/S2214750023000392

Ocular safety of intravitreal ethylene diamine tetra acetic ... The ERG test did not exhibit any significant alteration compared to the baseline values, except for a significant decrease in just one measurement of the eyes ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K232273.pdf

RetMap, Inc. Shresta Patangay Chief of Staff 832 W Superior ... Performance data demonstrated biocompatibility, absence of ocular irritation in both animals and humans, and substantially equivalent ...

10. direct.mit.edu direct.mit.edu/books/edited-volume/chapter-pdf/2446775/9780262275187_caq.pdf

17 Electrodes for Visual Testing Eye movement and electrode movement are two sources of potential artifact that can greatly affect the quality of ERG recordings. Electrode ...