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
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Healthy
• Macular Degeneration
• Macular Edema

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