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Sensor

Retinal Health Sensor Evaluation for Electrode Site Reaction

Phase < 1
Waitlist Available
Led By Michael Chaglasian, OD
Research Sponsored by RetMap, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks
Awards & highlights

Study Summary

This trial is testing a new ERG sensor (the RM Electrode) to see if it is as effective as the current standard (the ERG Jet Electrode). The study will also compare the two electrodes for ocular irritation.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include ocular irritation from wearing the contact lens electrodes during the test sessions. Each session lasts about 20 minutes with breaks in between.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Arm 2: Ocular irritation using clinical grading scales
Arm1: ERG signal quality, including peak amplitudes, noise levels, and signal to noise ratios.

Trial Design

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.

Find a Location

Who is running the clinical trial?

Illinois College of OptometryOTHER
6 Previous Clinical Trials
262 Total Patients Enrolled
RetMap, IncLead Sponsor
University of Illinois at ChicagoOTHER
602 Previous Clinical Trials
1,558,421 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this clinical trial still ongoing?

"Unfortunately, the details hosted on clinicaltrials.gov indicate that this medical investigation is not presently accepting patients. Originally posted in November of 2022 and recently amended in October of 2022, there are 1 other trials seeking volunteers at present."

Answered by AI
~45 spots leftby Mar 2025