Healthy, Macular Degeneration, Macular Edema
Conditions
Keywords
Electroretinography, ERG
Brief summary
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
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.
Interventions
DEVICEERG 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.
DEVICEFundus image-guided focal ERG
Record focal ERG from a healthy retinal area and from an area with visible symptoms.
Sponsors
Maculaser Oy
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Signal-to-noise ratio of focal electroretinography signal | Through study completion, an average of 1 year | Signal-to-noise ratio of the focal ERG signals with different ERG electrodes. |
| Focal ERG from symptomatic retinal area | Through study completion, an average of 1 year | Explore the device feasibility in recording focal ERG signal from areas with macular edema or macular degeneration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient comfort and usability of different ERG electrodes in focal ERG. | Through study completion, an average of 1 year | Investigated using a questionnaire for the subjects and investigator. |
Countries
Finland
Outcome results
None listed