Fundus Image-guided Focal Electroretinography, Usability Study

Not Applicable

Completed

• Conditions: Macular Edema; Healthy; Macular Degeneration
• Interventions: Device: ERG electrode tests for fundus image-guided focal ERG; Device: Fundus image-guided focal ERG

• Registration Number: NCT05100511
• Lead Sponsor: Maculaser Oy

Brief 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.

Study Timeline

• Study First Submitted: 2021-10-06
• Study First Submitted QC: 2021-10-19
• Study First Posted: 2021-10-29
• Status Verified: 2021-11
• Study Start: 2021-11-04
• Primary Completion: 2022-08-25
• Study Completion: 2022-08-25
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase I, healthy subjects	ERG electrode tests for fundus image-guided focal ERG	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.
Phase II, patients with macular edema or macular degeneration	Fundus image-guided focal ERG	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).

Primary Outcome Measures

Name	Time	Method
Signal-to-noise ratio of focal electroretinography signal	Through study completion, an average of 1 year	Signal-to-noise ratio of the focal ERG signals with different ERG electrodes.
Focal ERG from symptomatic retinal area	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 Outcome Measures

Name	Time	Method
Patient comfort and usability of different ERG electrodes in focal ERG.	Through study completion, an average of 1 year	Investigated using a questionnaire for the subjects and investigator.

Trial Locations

Locations (1)

Helsinki University Hospital, Retinal Outpatient Clinic; 🇫🇮 Helsinki, Uusimaa, Finland