Clinical trial NCT06991127: Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection
Official title: Pre-market Multicentric Cross-sectional Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Eyes
Lead sponsor: Centervue SpA
Sponsor class: INDUSTRY
First posted: 2025-05-25
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: To determine the reference normative values of retinal sensitivity for MAIA
timeFrame: 1 day
Secondary outcomes:
measure: To assess the avoidance of Serious Adverse Device Effects with MAIA
timeFrame: through study completion (expected duration: 10 months)
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: The Eye Care Institute
state: Florida
city: Perth
country: Australia
facility: UWA Eye Health Centre of Western Australia
state: Western Australia
city: Basel
country: Switzerland
facility: Universitätsspital Basel, Augenklinik
Study officials:
affiliation: Universitätsspital Basel, Augenklinik
name: Maximilian Pfau, PD Dr. med.
role: STUDY_CHAIR
References: