NCT06991127

Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection

Pre-market Multicentric Cross-sectional Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 380 (estimated)
• Sponsor: Centervue SpA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Eyes

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2025-04-23
• Primary completion: 2026-05-01
• Completion: 2026-06-01
• First posted: 2025-05-25
• Last updated: 2025-05-25

Locations

3 sites across 3 countries: United States, Australia, Switzerland

Regulatory

• FDA-regulated device study