Fundus Image-guided Focal Electroretinography, Usability Study

Maculaser Oy20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy Macular Edema Macular Degeneration

Interventions

ERG electrode tests for fundus image-guided focal ERGDEVICE

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

Fundus image-guided focal ERGDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Helsinki University Hospital, Retinal Outpatient Clinic

Helsinki, Uusimaa, Finland

Outcomes

Primary Outcomes

Signal-to-noise ratio of focal electroretinography signal

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

Time frame: 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.

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

Secondary Outcomes

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

Investigated using a questionnaire for the subjects and investigator.

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

Data from ClinicalTrials.gov

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