Menu
Enrolling by invitation NCT05509608

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

Early Phase I Interventional Electrode Site Reaction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RM Electrode, ERG Jet Electrode.
Who it may be relevant to
Registry conditions: Electrode Site Reaction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of an Electroretinogram Sensor

Overview

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

  • Device RM 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.
  • Device ERG Jet Electrode
    The ERG Jet electrode is an FDA approved, commercially available corneal ERG electrode.

Primary outcome measures

  • Arm1: ERG signal quality, including peak amplitudes, noise levels, and signal to noise ratios. [Time frame: Up to 24 weeks]
  • Arm 2: Ocular irritation using clinical grading scales [Time frame: Up to 24 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 2 centers
  • UIC Department of Ophthalmology & Visual Sciences — Chicago
  • Illinois College of Optometry — Chicago

Publications

  • 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. PMID 25502644
  • 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. PMID 33492495

Identifiers

NCT: NCT05509608 · RMEFDA2022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗