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Clinical Investigation of a New Version of MAIA Microperimeter on Healthy Subjects and Patients With Retinal Pathology

NCT06071546 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2024-08-13

No results posted yet for this study

Summary

The purpose of this pre-market, monocentric cross-sectional study is to evaluate the clinical usefulness of a new version of the MAIA device (MAIA) through an agreement with the established version of the MAIA microperimeter (MAIA 2013 EDITION). Moreover, the study aims to evaluate MAIA test-retest repeatability in comparison with MAIA 2013 EDITION and to evaluate MAIA safety and adverse events. These purposes will be achieved by collecting data of healthy subjects and patients with retinal pathology. All participants will undergo repeated microperimetric examinations with both devices during one single visit.

Conditions

Interventions

DEVICE

MAIA

MAIA is a visual field testing device combining visual field tests, fixation loss correction by a real-time retinal tracker and confocal TrueColor fundus imaging (P/N AHMACME001)

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
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-17
Primary Completion
2024-07-12
Completion
2024-07-12

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT06071546 on ClinicalTrials.gov