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Compensation: Varies

Number of Visits: 40

90 Participants Needed

Retinal Health Sensor Evaluation for Electrode Site Reaction

Recruiting at 1 trial location

Overseen ByChief Technology Officer

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: RetMap, Inc

Disqualifiers: Pregnancy, Retinal disease, Ocular surgery, others

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

Trial Summary

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 data supports the effectiveness of the treatment ERG Jet Electrode, RM Electrode?

The research suggests that modified ERG-jet contact lens electrodes, which are similar to the ERG Jet Electrode, provide comparable results to standard electroretinogram electrodes, even in infants and toddlers. This indicates that the ERG Jet Electrode can effectively record electroretinogram responses.¹ ² ³ ⁴ ⁵

Is the ERG Jet Electrode safe for use in humans?

The ERG Jet Electrode, used for recording eye responses, has been modified for use in infants and toddlers without needing sedation, and waveforms are comparable to standard electrodes, suggesting it is safe. Additionally, a new non-corneal electrode was found safe and reliable for similar recordings.¹ ² ³ ⁶ ⁷

How does the ERG Jet Electrode, RM Electrode treatment differ from other treatments for retinal health?

The ERG Jet Electrode and RM Electrode treatment is unique because it uses specialized electrodes to measure electroretinogram (ERG) responses, which can provide more precise data compared to traditional skin or corneal electrodes. This approach may offer improved accuracy in assessing retinal health by capturing more detailed electrical activity from the retina.¹ ² ⁵ ⁸ ⁹

What is the purpose of this trial?

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 subject of this study is the RM Electrode, a new ERG sensor developed by RetMap, Inc. The RM Electrode is not yet approved by the FDA. The testing described in this study has been requested by the FDA (pre-submission feedback) in support of the 510k application for the RM Electrode. ERG Jet Electrode (Fabrinal, Switzerland) will be used as the predicate device for comparison.The first Aim of the present study is to compare the functionality of the RM Electrode and the ERG Jet. 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 the ERG Jet Electrode. A typical ERG test session lasts 20 minutes. Ten healthy (normally-sighted) adult subjects will wear the RM Electrode on one eye and the ERG Jet 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.

Research Team

Robert Hyde, MD/PhD

Principal Investigator

UIC Department of Ophthalmology & Visual Sciences

Michael Chaglasian, OD

Principal Investigator

Illinois College of Optometry

Eligibility Criteria

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.

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Timeline

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

Treatment Details

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.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Ocular IrritationExperimental Treatment2 Interventions

Ocular Irritation: Ten healthy (normally-sighted) adult subjects will wear the RM Electrode in one eye and the ERG Jet 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 QualityExperimental Treatment2 Interventions

Electroretinogram Signal Quality: This Arm will participate in a comparative study using two ERG sensors, one commercially available (ERG Jet 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.