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Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection

NCT06991127 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2025-05-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Centervue SpA

    lead INDUSTRY

Principal Investigators

  • Maximilian Pfau, PD Dr. med. · Universitätsspital Basel, Augenklinik

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-23
Primary Completion
2026-05-01
Completion
2026-06-01
FDA Device
Yes

Countries

  • United States
  • Australia
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06991127 on ClinicalTrials.gov