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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
Scientific title
Pre-market Multicentric Cross-sectional Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection
Secondary ID [1] 0 0
MAIA_003_MNDB
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Eyes 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine the reference normative values of retinal sensitivity for MAIA
Timepoint [1] 0 0
1 day
Secondary outcome [1] 0 0
To assess the avoidance of Serious Adverse Device Effects with MAIA
Timepoint [1] 0 0
through study completion (expected duration: 10 months)

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/04/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
380
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
UWA Eye Health Centre of Western Australia - Perth
Recruitment postcode(s) [1] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
Switzerland
State/province [2] 0 0
Basel

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Centervue SpA
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Maximilian Pfau, PD Dr. med.
Address 0 0
Universitätsspital Basel, Augenklinik
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Maximilian Pfau, PD Dr. med.
Address 0 0
Country 0 0
Phone 0 0
78 215 42 67
Fax 0 0
Email 0 0
[email protected]
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