HealthyNCT05100511
Fundus Image-guided Focal Electroretinography, Usability Study
A study testing ERG electrode tests for fundus image-guided focal ERG and Fundus image-guided focal ERG in people with Healthy and Macular Edema, run by Maculaser Oy at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Macular Edema, Macular Degeneration
- What is being tested?
- ERG electrode tests for fundus image-guided focal ERG and Fundus image-guided focal ERG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- 4 Nov 2021to 25 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Epileptic patients
- Vulnerable population: pregnant and breastfeeding women, underage, prisoners, persons with physical handicaps or mental disabilities, and disadvantaged persons.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Helsinki University Hospital, Retinal Outpatient Clinic
Helsinki, Uusimaa, 00280
About this study
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.
Read the 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.
- Conditions
- Healthy, Macular Edema, Macular Degeneration
- Being tested
- ERG electrode tests for fundus image-guided focal ERG, Fundus image-guided focal ERG
- Keywords
- Electroretinography, ERG
- Medical subject headings
- Macular Edema, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERG electrode tests for fundus image-guided focal ERGDevice
Investigate the patient comfort, usability and signal-to-noise ratio of different commercial CE marked ERG electrodes.
Fundus image-guided focal ERGDevice
Record focal ERG from a healthy retinal area and from an area with visible symptoms.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Device: Fundus image-guided focal ERG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal-to-noise ratio of focal electroretinography signal
Signal-to-noise ratio of the focal ERG signals with different ERG electrodes.
Measured: 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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Patient comfort and usability of different ERG electrodes in focal ERG.
Investigated using a questionnaire for the subjects and investigator.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start4 Nov 2021
- Primary completion25 Aug 2022
- Study completion25 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maculaser Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joni Turunen, MD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100511
- Sponsor's protocol ID
- MACULARERG01
- Status last verified
- Nov 2021
- First submitted
- 6 Oct 2021
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fundus Image-guided Focal Electroretinography, Usability Study
- ClinicalTrials.gov ID
- NCT05100511
- Acronym / sponsor ID
- MACULARERG01
- Conditions
- Healthy, Macular Edema, Macular Degeneration
- Keywords
- Electroretinography, ERG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Maculaser OyIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 25 Aug 2022 (actual)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Phase I, healthy subjects | Experimental | Device: ERG electrode tests for fundus image-guided focal ERGGeneral 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 | Experimental | Device: Fundus image-guided focal ERGThe 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Epileptic patients
- Vulnerable population: pregnant and breastfeeding women, underage, prisoners, persons with physical handicaps or mental disabilities, and disadvantaged persons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERG electrode tests for fundus image-guided focal ERGInvestigate the patient comfort, usability and signal-to-noise ratio of different commercial CE marked ERG electrodes. | Device | Phase I, healthy subjects |
| Fundus image-guided focal ERGRecord focal ERG from a healthy retinal area and from an area with visible symptoms. | Device | Phase II, patients with macular edema or macular degeneration |
Primary outcome
Signal-to-noise ratio of focal electroretinography signal
Time frame: 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
Time frame: 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.
1 secondary outcome
Patient comfort and usability of different ERG electrodes in focal ERG.
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joni Turunen, MD principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERG electrode tests for fundus image-guided focal ERG and Fundus image-guided focal ERG in people with Healthy and Macular Edema, run by Maculaser Oy at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signal-to-noise ratio of focal electroretinography signal (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022; AzTrials last refreshed its copy on 28 Oct 2026.