Fundus Image-guided Focal Electroretinography, Usability Study

Maculaser

Status: Completed

Conditions: Healthy; Macular Degeneration; Macular Edema

Treatments: Device: ERG electrode tests for fundus image-guided focal ERG; Device: Fundus image-guided focal ERG

Study type: Interventional

Funder types: Industry

Identifiers

NCT05100511

MACULARERG01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Phase I, healthy subjects

Experimental group

Description:

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.

Treatment:

Device: ERG electrode tests for fundus image-guided focal ERG

Phase II, patients with macular edema or macular degeneration

Experimental group

Description:

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).

Treatment:

Device: Fundus image-guided focal ERG