NCT05100511

Fundus Image-guided Focal Electroretinography, Usability Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Maculaser Oy · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy
• Macular Edema
• Macular Degeneration

Interventions

Type	Name	Description
DEVICE	ERG 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.
DEVICE	Fundus image-guided focal ERG	Record focal ERG from a healthy retinal area and from an area with visible symptoms.

Timeline

• Start date: 2021-11-04
• Primary completion: 2022-08-25
• Completion: 2022-08-25
• First posted: 2021-10-29
• Last updated: 2022-11-08

Locations

1 site across 1 country: Finland