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

NCT05509608 | Enrolling By Invitation Early Phase 1 FDA Device

• 1 other identifier: RMEFDA2022
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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. 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

Keywords

Electroretinogram; Sensor; Retina; Contact lens; Electrode; Efficacy; Feasibility

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  Up to 24 weeks

Study Arms (2)

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.

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.

Device: RM Electrode; Device: ERG Jet Electrode

Interventions

RM Electrode DEVICE

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.

Electroretinogram Signal Quality; Ocular Irritation

ERG Jet Electrode DEVICE

The ERG Jet electrode is an FDA approved, commercially available corneal ERG electrode.

Electroretinogram Signal Quality; Ocular Irritation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons 18 and over.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RetMap, Inc: lead
• University of Illinois at Chicago: collaborator
• Illinois College of Optometry: collaborator

Study Sites (2)

UIC Department of Ophthalmology & Visual Sciences

Chicago, Illinois, 60612, United States

Location

Illinois College of Optometry

Chicago, Illinois, 60616, United States

Location

Related Publications (2)

• 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.

  PMID: 25502644 BACKGROUND

• Hoffmann 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.

  PMID: 33492495 BACKGROUND

Study Officials

• Robert Hyde, MD/PhD

  UIC Department of Ophthalmology & Visual Sciences

  PRINCIPAL INVESTIGATOR

• Michael Chaglasian, OD

  Illinois College of Optometry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: August 22, 2022
• Study Start: March 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 14, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)