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Fundus Image-guided Focal Electroretinography, Usability Study

Primary Purpose

Healthy, Macular Edema, Macular Degeneration

Status

Completed

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

ERG electrode tests for fundus image-guided focal ERG

Fundus image-guided focal ERG

About this trial

This is an interventional other trial for Healthy focused on measuring Electroretinography, ERG

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

Helsinki University Hospital, Retinal Outpatient Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Phase I, healthy subjects

Phase II, patients with macular edema or macular degeneration

Arm 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.

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).

Outcomes

Primary Outcome Measures

Signal-to-noise ratio of focal electroretinography signal

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

Focal ERG from symptomatic retinal area

Explore the device feasibility in recording focal ERG signal from areas with macular edema or macular degeneration.

Secondary Outcome Measures

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

Investigated using a questionnaire for the subjects and investigator.

Full Information

NCT ID

NCT05100511

First Posted

October 6, 2021

Last Updated

November 7, 2022

Sponsor

Maculaser Oy

1. Study Identification

Unique Protocol Identification Number

NCT05100511

Brief Title

Fundus Image-guided Focal Electroretinography, Usability Study

Official Title

Fundus Image-guided Focal Electroretinography, Usability Study

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

November 4, 2021 (Actual)

Primary Completion Date

August 25, 2022 (Actual)

Study Completion Date

August 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maculaser Oy

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Macular Edema, Macular Degeneration

Keywords

Electroretinography, ERG

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phase I, healthy subjects

Arm Type

Experimental

Arm Description

Arm Title

Phase II, patients with macular edema or macular degeneration

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

ERG electrode tests for fundus image-guided focal ERG

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Fundus image-guided focal ERG

Intervention Description

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

Primary Outcome Measure Information:

Title

Signal-to-noise ratio of focal electroretinography signal

Description

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

Time Frame

Through study completion, an average of 1 year

Title

Focal ERG from symptomatic retinal area

Description

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 Outcome Measure Information:

Title

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

Description

Investigated using a questionnaire for the subjects and investigator.

Time Frame

Through study completion, an average of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joni Turunen, MD

Organizational Affiliation

Helsinki University Central Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Helsinki University Hospital, Retinal Outpatient Clinic

City

Helsinki

State/Province

Uusimaa

ZIP/Postal Code

00280

Country

Finland

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Fundus Image-guided Focal Electroretinography, Usability Study

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