RecruitingNot ApplicableNCT06991127

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


Sponsor

Centervue SpA

Enrollment

380 participants

Start Date

Apr 23, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is building a normal reference database for a type of eye test called mesopic microperimetry, which measures how well your central vision works in dim lighting. Researchers need healthy participants to establish what 'normal' results look like. **You may be eligible if...** - You are 18 or older - You have good vision (20/25 or better, with or without glasses) - Your eye pressure is normal (21 mmHg or below) - Your optic nerve and retina appear healthy on examination - You have no history of significant eye problems or surgery (other than uncomplicated cataract surgery more than 6 months ago) **You may NOT be eligible if...** - You have been diagnosed with glaucoma or are suspected of having it - You have a history of high eye pressure - You have diabetic retinopathy or other retinal diseases - You take medications that could affect your vision test results - You have amblyopia (lazy eye) or poor fixation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEMAIA

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.


Locations(3)

The Eye Care Institute

Fort Lauderdale, Florida, United States

UWA Eye Health Centre of Western Australia

Perth, Western Australia, Australia

Universitätsspital Basel, Augenklinik

Basel, Switzerland, Switzerland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06991127