Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection

Part of paid clinical trials in Fort Lauderdale, Florida.

Sponsor
Centervue SpA
Study ID
NCT06991127
Status
Recruiting
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Conditions

  • Healthy Eyes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Apr 23, 2025
Status verified
Apr 2025
Primary completion
May 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
380 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Main Arm
    \*) one microperimetric examination with MAIA

Primary Outcome Measure

To determine the reference normative values of retinal sensitivity for MAIA [ Time Frame: 1 day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Eye Care InstituteFort LauderdaleFlorida33312
Julie Rodman, Professor
[email protected]
(954) 262-4274
Julie Rodman, Professor (PRINCIPAL_INVESTIGATOR)

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The Eye Care Institute· Fort Lauderdale, FL