Clinical trial NCT05509608: Evaluating a New Sensor That Measures the Health of the Retina in Normally-sighted Subjects
Official title: Evaluation of an Electroretinogram Sensor
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Electrode Site Reaction
Keywords: Electroretinogram
Sensor
Retina
Contact lens
Electrode
Efficacy
Feasibility
Lead sponsor: RetMap, Inc
Sponsor class: INDUSTRY
Collaborators: name: University of Illinois at Chicago
name: Illinois College of Optometry
First posted: 2022-08-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Arm1: ERG signal quality, including peak amplitudes, noise levels, and signal to noise ratios.
timeFrame: Up to 24 weeks
measure: Arm 2: Ocular irritation using clinical grading scales
timeFrame: Up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: UIC Department of Ophthalmology & Visual Sciences
state: Illinois
city: Chicago
country: United States
facility: Illinois College of Optometry
state: Illinois
Study officials:
affiliation: UIC Department of Ophthalmology & Visual Sciences
name: Robert Hyde, MD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Illinois College of Optometry
name: Michael Chaglasian, OD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.