Fundus Image-guided Focal Electroretinography, Usability Study
NCT ID: NCT05100511
Last Updated: 2022-11-08
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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COMPLETED
NA
20 participants
INTERVENTIONAL
2021-11-04
2022-08-25
Brief Summary
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Detailed Description
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In phase I, the usability of the investigational device is tested with 10 healthy volunteers. The examinations include focal ERG and noise tests with commercial ERG electrodes. The stimulus lights are guided to the fundus using either non-contact of contact fundus lens. One electrode is selected for phase II based on signal-to-noise ration, usability, and comfort.
In phase II, fundus image-guided focal ERG recordings are conducted with total of 10 patients having either macular edema or macular degeneration. The aim of the phase II is to test whether the investigational device can be used to record focal ERG signal from the desired symptomatic retinal area.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
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Phase I, healthy subjects
General usability of the device is tested with healthy patients. Different commercial electroretinography electrodes are tested to investigate the patient comfort, usability and signal-to-noise ratio when recording fundus image-guided focal electroretinography with the investigational device. Most suitable electrode is selected to phase II.
ERG electrode tests for fundus image-guided focal ERG
Investigate the patient comfort, usability and signal-to-noise ratio of different commercial CE marked ERG electrodes.
Phase II, patients with macular edema or macular degeneration
The usability of the device is tested with patients suffering either from macular edema or macular degeneration. Fundus image-guided focal electroretinography is recorded with the electrode chosen in phase I from two different retinal areas: from an area with macular edema or signs of macular degeneration and from a healthy area (area without macular edema or signs of macular degeneration).
Fundus image-guided focal ERG
Record focal ERG from a healthy retinal area and from an area with visible symptoms.
Interventions
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ERG electrode tests for fundus image-guided focal ERG
Investigate the patient comfort, usability and signal-to-noise ratio of different commercial CE marked ERG electrodes.
Fundus image-guided focal ERG
Record focal ERG from a healthy retinal area and from an area with visible symptoms.
Eligibility Criteria
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Inclusion Criteria
* Patients with either macular edema or macular degeneration (phase II)
* Able to give informed consent
Exclusion Criteria
* Vulnerable population: pregnant and breastfeeding women, underage, prisoners, persons with physical handicaps or mental disabilities, and disadvantaged persons.
18 Years
80 Years
ALL
Yes
Sponsors
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Maculaser Oy
INDUSTRY
Responsible Party
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Principal Investigators
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Joni Turunen, MD
Role: PRINCIPAL_INVESTIGATOR
Helsinki University Central Hospital
Locations
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Helsinki University Hospital, Retinal Outpatient Clinic
Helsinki, Uusimaa, Finland
Countries
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Other Identifiers
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MACULARERG01
Identifier Type: -
Identifier Source: org_study_id
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