Fundus Image-guided Focal Electroretinography Usability Study

  • days left to enroll
  • participants needed
  • sponsor
    Maculaser Oy
Updated on 12 November 2021
macular edema
macular degeneration
Accepts healthy volunteers


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.


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.

Condition healthy, Macular Edema, Maculopathy, age-related macular degeneration, Macular Degeneration, Cystoid Macular Edema
Treatment ERG electrode tests for fundus image-guided focal ERG, Fundus image-guided focal ERG
Clinical Study IdentifierNCT05100511
SponsorMaculaser Oy
Last Modified on12 November 2021


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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