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

Conditions

• Electrode Site Reaction

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

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.
• ERG Jet Electrode — DEVICE
  The ERG Jet electrode is an FDA approved, commercially available corneal ERG electrode.

Study Details

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.

Key Dates

Start date

Mar 1, 2023

Status verified

Sep 2025

Primary completion

Dec 31, 2025

Completion

Dec 31, 2025

Study Design

Enrollment

90 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Arms

• 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.
• 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.

Primary Outcome Measure

Arm1: ERG signal quality, including peak amplitudes, noise levels, and signal to noise ratios. [ Time Frame: Up to 24 weeks ]

Locations (2)

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