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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06991127
Registration number
NCT06991127
Ethics application status
Date submitted
19/05/2025
Date registered
25/05/2025
Date last updated
25/05/2025
Titles & IDs
Public title
Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection
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Scientific title
Pre-market Multicentric Cross-sectional Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection
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Secondary ID [1]
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MAIA_003_MNDB
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy Eyes
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - MAIA
Experimental: Main Arm - \*) one microperimetric examination with MAIA
Treatment: Devices: MAIA
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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To determine the reference normative values of retinal sensitivity for MAIA
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Assessment method [1]
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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
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Timepoint [1]
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1 day
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Secondary outcome [1]
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To assess the avoidance of Serious Adverse Device Effects with MAIA
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Assessment method [1]
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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.
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Timepoint [1]
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through study completion (expected duration: 10 months)
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Eligibility
Key inclusion criteria
* 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;
* 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* 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;
* 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.
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Study design
Purpose of the study
Other
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/04/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2026
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Actual
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Sample size
Target
380
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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UWA Eye Health Centre of Western Australia - Perth
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Recruitment postcode(s) [1]
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6009 - Perth
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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Switzerland
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State/province [2]
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Basel
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Centervue SpA
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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. These purposes will be achieved by collecting data of healthy subjects, who will undergo microperimetric examinations with the MAIA device during one single visit.
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Trial website
https://clinicaltrials.gov/study/NCT06991127
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Maximilian Pfau, PD Dr. med.
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Address
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Universitätsspital Basel, Augenklinik
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Maximilian Pfau, PD Dr. med.
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Address
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Country
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Phone
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78 215 42 67
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Fax
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Email
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maximilian.pfau@usb.ch
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06991127
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