Healthy EyesNCT06071546
Clinical Investigation of a New Version of MAIA Microperimeter on Healthy Subjects and Patients With Retinal Pathology
A study testing MAIA in people with Healthy Eyes and Retinal Diseases, run by Centervue SpA at 1 site in Switzerland.
Trial summary
The purpose of this pre-market, monocentric cross-sectional study is to evaluate the clinical usefulness of a new version of the MAIA device (MAIA) through an agreement with the established version of the MAIA microperimeter (MAIA 2013 EDITION). Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Eyes, Retinal Diseases
- What is being tested?
- MAIA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Oct 2023to 12 Jul 2024
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18-90 years old;
- BCVA ≥ 0.8 Decimal;
- Equivalent spherical refraction between -12D and +6D; astigmatism within 2D;
- IOP ≤ 21 mmHg;
- Clinically normal appearance of the optic nerve head (examined with Spectralis OCT);
- Clinically normal appearance of the macula (examined with Spectralis OCT);
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- No ocular pathologies, trauma, surgeries;
- Absence of pathologies that can affect visual field;
- No use of drugs inferfering with the correct execution of perimetry;
- Age: 18-90 years old;
- BCVA ≥ 0.1 Decimal;
- Equivalent spherical refraction between -12D and +6D; astigmatism within 2D;
- Diagnosis of any type of retinal disease by investigator based on fundoscopy and Spectralis OCT for which microperimetry is indicated;
Who cannot join
- Glaucoma or glaucoma suspect diagnosis;
- IOP ≥ 22 mmHg;
- Presence or history of disc hemorrhage;
- Presence of amblyopia;
- Nystagmus or poor fixation;
- Previous laser or any ocular surgery, including uncomplicated cataract surgery performed within 6 months before enrollment;
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- Any active infection of anterior or posterior segments;
- Subjects with significant ocular media opacities;
- Evidence of diabetic retinopathy, diabetic macular edema, or other retinal disease;
- Use of any drug that can interfere with the correct execution of microperimetry or that would produce visual field loss;
- Unable to tolerate ophthalmic imaging;
- Claustrophobia;
- Inability to provide informed consent.
- Patients with retinal pathology
- Any ocular surgery, with the exception of uncomplicated cataract surgery performed at least 6 months before enrollment;
- Subjects unable to tolerate ophthalmic imaging;
- Nystagmus;
- Subjects with significant ocular media opacities;
- Use of any drug that can interfere with the correct execution of microperimetry or that would produce visual field loss;
- Claustrophobia;
- Inability to provide informed consent;
- Vulnerable subjects according to the investigator's judgement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-market Monocentric Cross-sectional Clinical Investigation of MAIA on Healthy Subjects and Patients With Retinal Pathology: Agreement With MAIA 2013 EDITION Microperimeter and Repeatability Evaluation
The purpose of this pre-market, monocentric cross-sectional study is to evaluate the clinical usefulness of a new version of the MAIA device (MAIA) through an agreement with the established version of the MAIA microperimeter (MAIA 2013 EDITION). Moreover, the study aims to evaluate MAIA test-retest repeatability in comparison with MAIA 2013 EDITION and to evaluate MAIA safety and adverse events. These purposes will be achieved by collecting data of healthy subjects and patients with retinal pathology. All participants will undergo repeated microperimetric examinations with both devices during one single visit.
- Conditions
- Healthy Eyes, Retinal Diseases
- Being tested
- MAIA
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAIADevice
MAIA is a visual field testing device combining visual field tests, fixation loss correction by a real-time retinal tracker and confocal TrueColor fundus imaging (P/N AHMACME001)
| Study group | Role | What they receive |
|---|---|---|
| Main arm | Experimental | * one microperimetric examination with MAIA, one microperimetric examination with MAIA 2013 EDITION for agreement evaluation;
* one additional microperimetric examination with MAIA and one additional microperimetric examination with MAIA 2013 EDITION for repetability evaluation. Receives: Device: MAIA |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the limits of agreement between MAIA and MAIA 2013 EDITION for threshold sensitivity values.
Agreement will be quantified by using the method proposed by Bland and Altman [1,2,3], estimating the 95%-Limits of Agreement (LoA) of the difference of threshold sensitivity values.
The acceptance criteria for agreement between MAIA and MAIA 2013 EDITION is that MAIA's 95% LoA limits are within MAIA 2013 EDITION repeatability limits.
- Bland JM, Altman DG (1986) Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1(8476):307-10.
- Bland JM, Altman DG (1999) Measuring agreement in method comparison studies. Statistical Methods in Medical Research 8:135-160
- Bland JM, Altman DG (2007), Agreement Between Methods of Measurement with Multiple Observations Per Individual, Journal of Biopharmaceutical Statistics 17:571-82
Measured: 1 day
Secondary outcomes (2)
To assess the repeatability limits of retinal threshold sensitivity values obtained with MAIA
The acceptance criteria is that the 95% LoA limits for MAIA are at least as narrow as MAIA 2013 EDITION repeatability limits.
Measured: 1 day
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: 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start17 Oct 2023
- Primary completion12 Jul 2024
- Study completion12 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centervue SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maximilian Pfau, PD Dr. med., Principal investigator, Universitätsspital Basel, Augenklinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071546
- Sponsor's protocol ID
- MAIA_003_MAG
- Status last verified
- Aug 2024
- First submitted
- 22 Sep 2023
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ansari G, Giudici NL, Cancian G, Rossouw P, Rui C, Rosso A, Gazzina S, Feltgen N, Pfau K, Pfau M. Validation and Repeatability of Differential Light Sensitivity Measurements with the Novel MAIA Microperimetry Device. Ophthalmol Sci. 2025 Jul 16;5(6):100886. doi: 10.1016/j.xops.2025.100886. eCollection 2025 Nov-Dec.
PubMed 40980023
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-market Monocentric Cross-sectional Clinical Investigation of MAIA on Healthy Subjects and Patients With Retinal Pathology: Agreement With MAIA 2013 EDITION Microperimeter and Repeatability Evaluation
- ClinicalTrials.gov ID
- NCT06071546
- Acronym / sponsor ID
- MAIA_003_MAG
- Conditions
- Healthy Eyes, Retinal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Centervue SpAIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 6 Oct 2023 (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, monocentric cross-sectional study is to evaluate the clinical usefulness of a new version of the MAIA device (MAIA) through an agreement with the established version of the MAIA microperimeter (MAIA 2013 EDITION). Moreover, the study aims to evaluate MAIA test-retest repeatability in comparison with MAIA 2013 EDITION and to evaluate MAIA safety and adverse events. These purposes will be achieved by collecting data of healthy subjects and patients with retinal pathology. All participants will undergo repeated microperimetric examinations with both devices 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, one microperimetric examination with MAIA 2013 EDITION for agreement evaluation; * one additional microperimetric examination with MAIA and one additional microperimetric examination with MAIA 2013 EDITION for repetability evaluation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age: 18-90 years old;
- BCVA ≥ 0.8 Decimal;
- Equivalent spherical refraction between -12D and +6D; astigmatism within 2D;
- IOP ≤ 21 mmHg;
- Clinically normal appearance of the optic nerve head (examined with Spectralis OCT);
Key exclusion criteria (22 listed)
- Glaucoma or glaucoma suspect diagnosis;
- IOP ≥ 22 mmHg;
- Presence or history of disc hemorrhage;
- Presence of amblyopia;
- Nystagmus or poor fixation;
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 a visual field testing device combining visual field tests, fixation loss correction by a real-time retinal tracker and confocal TrueColor fundus imaging (P/N AHMACME001) | Device | Main arm |
Primary outcome
To evaluate the limits of agreement between MAIA and MAIA 2013 EDITION for threshold sensitivity values.
Time frame: 1 day
Agreement will be quantified by using the method proposed by Bland and Altman [1,2,3], estimating the 95%-Limits of Agreement (LoA) of the difference of threshold sensitivity values. The acceptance criteria for agreement between MAIA and MAIA 2013 EDITION is that MAIA's 95% LoA limits are within MAIA 2013 EDITION repeatability limits. 1. Bland JM, Altman DG (1986) Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1(8476):307-10. 2. Bland JM, Altman DG (1999) Measuring agreement in method comparison studies. Statistical Methods in Medical Research 8:135-160 3. Bland JM, Altman DG (2007), Agreement Between Methods of Measurement with Multiple Observations Per Individual, Journal of Biopharmaceutical Statistics 17:571-82
2 secondary outcomes
To assess the repeatability limits of retinal threshold sensitivity values obtained with MAIA
Time frame: 1 day
To assess the avoidance of Serious Adverse Device Effects with MAIA
Time frame: through study completion (expected duration: 3 months)
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 13 Aug 2024.
- Derived from this study: PubMed 40980023Ansari G, Giudici NL, Cancian G, Rossouw P, Rui C, Rosso A, Gazzina S, Feltgen N, Pfau K, Pfau M. Validation and Repeatability of Differential Light Sensitivity Measurements with the Novel MAIA Microperimetry Device. Ophthalmol Sci. 2025 Jul 16;5(6):100886. doi: 10.1016/j.xops.2025.100886. eCollection 2025 Nov-Dec.
- 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.
Maximilian Pfau, PD Dr. med. principal investigator
Universitätsspital Basel, Augenklinik
1 site in 1 country: 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 and Retinal Diseases, run by Centervue SpA at 1 site in Switzerland.
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 13 inclusion and 22 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 13 Aug 2024. 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 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?
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?
To evaluate the limits of agreement between MAIA and MAIA 2013 EDITION for threshold sensitivity values. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06071546, which also lists 1 linked publication.
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 13 Aug 2024.