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Completed

NCT Number: NCT05100511

Fundus Image-guided Focal Electroretinography, Usability Study

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.

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Key information

Conditions

Healthy Eye Diseases Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital, Retinal Outpatient Clinic

Helsinki, Uusimaa, 00280, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ERG electrode tests for fundus image-guided focal ERG

Device

Investigate the patient comfort, usability and signal-to-noise ratio of different commercial CE marked ERG electrodes.

Fundus image-guided focal ERG

Device

Record focal ERG from a healthy retinal area and from an area with visible symptoms.

Primary outcomes

  1. Signal-to-noise ratio of focal electroretinography signal

    Time frame: Through study completion, an average of 1 year

    Signal-to-noise ratio of the focal ERG signals with different ERG electrodes.

  2. Focal ERG from symptomatic retinal area

    Time frame: 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 outcomes

  1. Patient comfort and usability of different ERG electrodes in focal ERG.

    Time frame: Through study completion, an average of 1 year

    Investigated using a questionnaire for the subjects and investigator.

Sponsors and collaborators

Lead sponsor

Maculaser Oy

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 29, 2021
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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