Fundus Image-guided Focal Electroretinography, Usability Study

Study Overview
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Brief Summary
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The purpose of this study is to investigate the usability of fundus image-guided focal electroretinography device with healthy subjects and with macular edema and macular degeneration patients.

Detailed Description
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In this study, we will study the usability of focal electroretinography device combined with slit lamp biomicroscope. The device allows simultaneous fundus imaging and focal ERG recording from the desired retinal area. 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.

Official Title
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Fundus Image-guided Focal Electroretinography, Usability Study

Conditions
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Healthy, Macular Edema, Macular Degeneration

Intervention / Treatment
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* Device: ERG electrode tests for fundus image-guided focal ERG
* Device: Fundus image-guided focal ERG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers with no signs of macular edema or macular degeneration (phase I) Patients with either macular edema or macular degeneration (phase II) Able to give informed consent Exclusion Criteria: Epileptic patients Vulnerable population: pregnant and breastfeeding women, underage, prisoners, persons with physical handicaps or mental disabilities, and disadvantaged persons.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: The usability of the investigational device is examined first with 10 healthy subjects and afterwards with total of 10 patients suffering either from macular edema or macular degeneration.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase I, healthy subjects<br>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. | Device: ERG electrode tests for fundus image-guided focal ERG<br>* Investigate the patient comfort, usability and signal-to-noise ratio of different commercial CE marked ERG electrodes.<br>|
| Experimental: Phase II, patients with macular edema or macular degeneration<br>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). | Device: Fundus image-guided focal ERG<br>* Record focal ERG from a healthy retinal area and from an area with visible symptoms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signal-to-noise ratio of focal electroretinography signal | Signal-to-noise ratio of the focal ERG signals with different ERG electrodes. | Through study completion, an average of 1 year | 
| Focal ERG from symptomatic retinal area | Explore the device feasibility in recording focal ERG signal from areas with macular edema or macular degeneration. | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient comfort and usability of different ERG electrodes in focal ERG. | Investigated using a questionnaire for the subjects and investigator. | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electroretinography, ERG