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

Early Phase 1

Active, not recruiting

• Conditions: Electrode Site Reaction
• Interventions: Device: RM Electrode; Device: ERG Jet Electrode

• Registration Number: NCT05509608
• Lead Sponsor: RetMap, Inc

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-14
• Study First Submitted QC: 2022-08-18
• Study First Posted: 2022-08-22
• Study Start: 2023-03-01
• Status Verified: 2024-05
• Last Update Submitted: 2025-01-12
• Last Update Posted: 2025-01-14
• Primary Completion: 2025-05-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electroretinogram Signal Quality	RM Electrode	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.
Electroretinogram Signal Quality	ERG Jet Electrode	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.
Ocular Irritation	ERG Jet Electrode	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.
Ocular Irritation	RM Electrode	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.

Primary Outcome Measures

Name	Time	Method
Arm1: ERG signal quality, including peak amplitudes, noise levels, and signal to noise ratios.	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.
Arm 2: Ocular irritation using clinical grading scales	Up to 24 weeks	Slit-lamp examination and standard clinical grading scales for bulbar redness, limbal redness, tarsal redness, and corneal staining (fluorescein).

Trial Locations

Locations (2)

UIC Department of Ophthalmology & Visual Sciences; 🇺🇸 Chicago, Illinois, United States

Illinois College of Optometry; 🇺🇸 Chicago, Illinois, United States