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

Study Overview
=================
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.

Official Title
-----------------
Evaluation of an Electroretinogram Sensor

Conditions
-----------------
Electrode Site Reaction

Intervention / Treatment
-----------------
* Device: RM Electrode
* Device: ERG Jet Electrode


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electroretinogram, Sensor, Retina, Contact lens, Electrode, Efficacy, Feasibility