Healthy EyesNCT06991127
Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection
A study testing MAIA in people with Healthy Eyes, run by Centervue SpA at 3 sites in 3 countries.
Trial summary
The purpose of this pre-market, multicentric cross-sectional study is to create a mesopic Normative Database for a new version of the MAIA device. Moreover, the study aims to evaluate MAIA safety and adverse events. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Eyes
- What is being tested?
- MAIA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 23 Apr 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: ≥18 years old;
- Best Corrected Visual Acuity (BCVA): ≥ 0.8 Decimal (≥ 20/25 ft, ≤ +0.1 logMAR) at least in the study eye;
- Equivalent spherical refraction between the range ≥ -6D and ≤ +6D; astigmatism within 2D (≤ 2D) at least in the study eye;
- Intraocular Pressure (IOP) ≤ 21 mmHg in both eyes (Goldmann applanation tonometer);
- Clinically normal appearance of the optic nerve head according to clinical judgement (no evidence of excavation, rim thinning, notching, disc hemorrhages, RNFL thinning) in both eyes. This is examined with Spectralis or Solix OCT;
- Clinically normal appearance of the macula according to clinical judgement, in both eyes. This is examined with Spectralis or Solix OCT;
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- No ocular pathologies, trauma, surgeries (apart from uncomplicated cataract surgery or peripheral laser retinopexy performed at least 6 months before enrollment) in both eyes;
- Absence of pathologies that can affect visual field in both eyes;
- No use of drugs interfering with the correct execution of perimetry.
Who cannot join
- Glaucoma or glaucoma suspect diagnosis in either eye;
- Presence or history of ocular hypertension (IOP ≥ 22 mmHg) in either eye;
- Presence or history of disc hemorrhage in either eye;
- Presence of amblyopia in either eye;
- Nystagmus or poor fixation in either eye;
- Previous laser or any ocular surgery, including uncomplicated cataract surgery performed within 6 months before enrollment in both eyes;
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- Any active infection of anterior or posterior segments in the study eye;
- Subjects with significant ocular media opacities preventing acquisition of acceptable infrared (IR) fundus image quality in the study eye;
- Evidence of diabetic retinopathy, diabetic macular edema, or other retinal disease in either eye;
- Use of any drug that can interfere with the correct execution of MP or that would produce visual field loss;
- Unable to tolerate ophthalmic imaging;
- Claustrophobia;
- Inability to provide informed consent.
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
United States1 site, 1 recruiting
- Not yet recruiting
The Eye Care Institute
Fort Lauderdale, Florida, 33312
Julie Rodman, Professor, (954) 262-4274, rjulie@nova.edu
Julie Rodman, Professor
Australia1 site, 1 recruiting
- Not yet recruiting
UWA Eye Health Centre of Western Australia
Perth, Western Australia, 6009
Allison McKendrick, Professor, 8 64887409 ext. +61, allison.mckendrick@uwa.edu.au
Allison McKendrick, Professor
Switzerland1 site, 1 recruiting
- Recruiting
Universitätsspital Basel, Augenklinik
Basel, Switzerland, CH-4031
Kristina Pfau, PD Dr. med., 78 480 38 37 ext. +41, kristina.pfau@usb.ch
Kristina Pfau, PD Dr. med.
About this study
Official title: Pre-market Multicentric Cross-sectional Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection
The purpose of this pre-market, multicentric cross-sectional study is to create a mesopic Normative Database for a new version of the MAIA device. Moreover, the study aims to evaluate MAIA safety and adverse events. These purposes will be achieved by collecting data of healthy subjects, who will undergo microperimetric examinations with the MAIA device during one single visit.
- Conditions
- Healthy Eyes
- Being tested
- MAIA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAIADevice
MAIA is an automatic microperimeter with fundus imaging capabilities that measures retinal sensitivity, fixation stability and locus of fixation, and allows the acquisition of confocal images of the retina, thanks to its confocal scanning imaging system which uses infrared and visible light.
| Study group | Role | What they receive |
|---|---|---|
| Main Arm | Experimental | *) one microperimetric examination with MAIA Receives: Device: MAIA |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the reference normative values of retinal sensitivity for MAIA
The reference normative values will be determined by using a linear regression model for Mean Sensitivity (MS) as a function of age. The 5th and 10th percentile values will be derived for each age, and will serve as age-adjusted normative data against which compare the MS computed during each test with MAIA
Measured: 1 day
Secondary outcomes (1)
To assess the avoidance of Serious Adverse Device Effects with MAIA
During the clinical investigation, adverse events will be documented, investigated and reported according to the provisions of applicable reporting guidelines, following their criteria and timelines.
Measured: through study completion (expected duration: 10 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start23 Apr 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy EyesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centervue SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maximilian Pfau, PD Dr. med., Study chair, Universitätsspital Basel, Augenklinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991127
- Sponsor's protocol ID
- MAIA_003_MNDB
- Status last verified
- Apr 2025
- First submitted
- 19 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-market Multicentric Cross-sectional Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection
- ClinicalTrials.gov ID
- NCT06991127
- Acronym / sponsor ID
- MAIA_003_MNDB
- Conditions
- Healthy Eyes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Centervue SpAIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 25 May 2025 (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 pre-market, multicentric cross-sectional study is to create a mesopic Normative Database for a new version of the MAIA device. Moreover, the study aims to evaluate MAIA safety and adverse events. These purposes will be achieved by collecting data of healthy subjects, who will undergo microperimetric examinations with the MAIA device during one single visit.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main Arm | Experimental | Device: MAIA*) one microperimetric examination with MAIA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: ≥18 years old;
- Best Corrected Visual Acuity (BCVA): ≥ 0.8 Decimal (≥ 20/25 ft, ≤ +0.1 logMAR) at least in the study eye;
- Equivalent spherical refraction between the range ≥ -6D and ≤ +6D; astigmatism within 2D (≤ 2D) at least in the study eye;
- Intraocular Pressure (IOP) ≤ 21 mmHg in both eyes (Goldmann applanation tonometer);
- Clinically normal appearance of the optic nerve head according to clinical judgement (no evidence of excavation, rim thinning, notching, disc hemorrhages, RNFL thinning) in both eyes. This is examined with Spectralis or Solix OCT;
Key exclusion criteria (13 listed)
- Glaucoma or glaucoma suspect diagnosis in either eye;
- Presence or history of ocular hypertension (IOP ≥ 22 mmHg) in either eye;
- Presence or history of disc hemorrhage in either eye;
- Presence of amblyopia in either eye;
- Nystagmus or poor fixation in either eye;
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 |
|---|---|---|
| MAIAMAIA is an automatic microperimeter with fundus imaging capabilities that measures retinal sensitivity, fixation stability and locus of fixation, and allows the acquisition of confocal images of the retina, thanks to its confocal scanning imaging system which uses infrared and visible light. | Device | Main Arm |
Primary outcome
To determine the reference normative values of retinal sensitivity for MAIA
Time frame: 1 day
The reference normative values will be determined by using a linear regression model for Mean Sensitivity (MS) as a function of age. The 5th and 10th percentile values will be derived for each age, and will serve as age-adjusted normative data against which compare the MS computed during each test with MAIA
1 secondary outcome
To assess the avoidance of Serious Adverse Device Effects with MAIA
Time frame: through study completion (expected duration: 10 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- 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.
Maximilian Pfau, PD Dr. med. study chair
Universitätsspital Basel, Augenklinik
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAIA in people with Healthy Eyes, run by Centervue SpA at 3 sites in 3 countries.
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 9 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Australia, Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maximilian Pfau, PD Dr. med. (78 215 42 67 ext. +41, maximilian.pfau@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the reference normative values of retinal sensitivity for MAIA (time frame: 1 day). 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 25 May 2025.