Fundus Image-guided Focal Electroretinography, Usability Study

NCT05100511 | Completed

• 1 other identifier: MACULARERG01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Macular Edema; Macular Degeneration

Keywords

Electroretinography; ERG

Outcome Measures

Primary Outcomes (2)

• Signal-to-noise ratio of focal electroretinography signal

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

  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.

  Through study completion, an average of 1 year

Secondary Outcomes (1)

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

  Through study completion, an average of 1 year

Study Arms (2)

Phase I, healthy subjects

EXPERIMENTAL

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.

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

Phase II, patients with macular edema or macular degeneration

EXPERIMENTAL

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).

Device: Fundus image-guided focal ERG

Interventions

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.

Phase I, healthy subjects

Fundus image-guided focal ERG DEVICE

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

Phase II, patients with macular edema or macular degeneration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Epileptic patients
• Vulnerable population: pregnant and breastfeeding women, underage, prisoners, persons with physical handicaps or mental disabilities, and disadvantaged persons.

Sponsors & Collaborators

• Maculaser Oy: lead

Study Sites (1)

Helsinki University Hospital, Retinal Outpatient Clinic

Helsinki, Uusimaa, 00280, Finland

Location

MeSH Terms

Conditions

Macular Edema; Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Joni Turunen, MD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The usability of the investigational device is examined first with 10 healthy subjects and afterwards with total of 10 patients suffering either from macular edema or macular degeneration.

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 29, 2021
• Study Start: November 4, 2021
• Primary Completion: August 25, 2022
• Study Completion: August 25, 2022
• Last Updated: November 8, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)