Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection

ConditionHealthy Eyes

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorCentervue SpA

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

MAIA
Device
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.

Treatment groups

380 Participants

are divided into 1 treatment group

Group A: Main ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

1 day

Secondary outcomes

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.

Time frame

through study completion (expected duration: 10 months)