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NCT05100511 Clinical Trial

Fundus Image-guided Focal Electroretinography, Usability Study

Healthy Clinical Trial

Official title:
Fundus Image-guided Focal Electroretinography, Usability Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05100511
Other study ID # MACULARERG01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 4, 2021
Est. completion date August 25, 2022

Study information
Verified date November 2021
Source Maculaser Oy
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date August 25, 2022
Est. primary completion date August 25, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.
• Fundus image-guided focal ERG
Record focal ERG from a healthy retinal area and from an area with visible symptoms.

Locations
Country Name City State
Finland Helsinki University Hospital, Retinal Outpatient Clinic Helsinki Uusimaa

Sponsors (1)
Lead Sponsor Collaborator
Maculaser Oy

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Patient comfort and usability of different ERG electrodes in focal ERG. Investigated using a questionnaire for the subjects and investigator. Through study completion, an average of 1 year
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