Electrode Site Reaction
Conditions
Keywords
Electroretinogram, Sensor, Retina, Contact lens, Electrode, Efficacy, Feasibility
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.
Interventions
DEVICERM 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.
DEVICEERG Jet Electrode
The ERG Jet electrode is an FDA approved, commercially available corneal ERG electrode.
Sponsors
RetMap, Inc
University of Illinois at Chicago
Illinois College of Optometry
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRobert Hyde, MD/PhD
UIC Department of Ophthalmology & Visual Sciences
PRINCIPAL_INVESTIGATORMichael Chaglasian, OD
Illinois College of Optometry
Outcome results
None listed