Evaluating a New Sensor That Measures the Health of the Retina in Normally-sighted Subjects

November 13, 2025 updated by: RetMap, Inc

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • UIC Department of Ophthalmology & Visual Sciences
      • Chicago, Illinois, United States, 60616
        • Illinois College of Optometry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Persons 18 and over.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electroretinogram Signal Quality
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.
Device: RM Electrode
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.
Device: ERG Jet Electrode
The ERG Jet electrode is an FDA approved, commercially available corneal ERG electrode.
Experimental: Ocular Irritation
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.
Device: RM Electrode
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.
Device: ERG Jet Electrode
The ERG Jet electrode is an FDA approved, commercially available corneal ERG electrode.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 24 weeks
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).
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RetMap, Inc

Collaborators

University of Illinois at Chicago
Illinois College of Optometry

Investigators

  • Principal Investigator: Robert Hyde, MD/PhD, UIC Department of Ophthalmology & Visual Sciences
  • Principal Investigator: Michael Chaglasian, OD, Illinois College of Optometry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

July 14, 2022

First Submitted That Met QC Criteria

August 18, 2022

First Posted (Actual)

August 22, 2022

Study Record Updates

Last Update Posted (Estimated)

November 14, 2025

Last Update Submitted That Met QC Criteria

November 13, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RMEFDA2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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