Evaluating a New Sensor That Measures the Health of the Retina in Normally-sighted Subjects
NCT ID: NCT05509608
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
EARLY_PHASE1
90 participants
INTERVENTIONAL
2023-03-01
2025-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
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.
OTHER
NONE
Study Groups
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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.
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.
ERG Jet Electrode
The ERG Jet electrode is an FDA approved, commercially available corneal ERG electrode.
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.
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.
ERG Jet Electrode
The ERG Jet electrode is an FDA approved, commercially available corneal ERG electrode.
Interventions
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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.
ERG Jet Electrode
The ERG Jet electrode is an FDA approved, commercially available corneal ERG electrode.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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University of Illinois at Chicago
OTHER
Illinois College of Optometry
OTHER
RetMap, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Hyde, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
UIC Department of Ophthalmology & Visual Sciences
Michael Chaglasian, OD
Role: PRINCIPAL_INVESTIGATOR
Illinois College of Optometry
Locations
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UIC Department of Ophthalmology & Visual Sciences
Chicago, Illinois, United States
Illinois College of Optometry
Chicago, Illinois, United States
Countries
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References
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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.
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.
Other Identifiers
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RMEFDA2022
Identifier Type: -
Identifier Source: org_study_id