Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection

NCT06991127 | Recruiting FDA Device

• 1 other identifier: MAIA_003_MNDB
• Study Type: interventional
• Target: 380
• Locations: 3 countries
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• To determine the reference normative values of retinal sensitivity for MAIA

  The reference normative values will be determined by using a linear regression model for Mean Sensitivity (MS) as a function of age. The 5th and 10th percentile values will be derived for each age, and will serve as age-adjusted normative data against which compare the MS computed during each test with MAIA

  1 day

Secondary Outcomes (1)

• To assess the avoidance of Serious Adverse Device Effects with MAIA

  through study completion (expected duration: 10 months)

Study Arms (1)

Main Arm

EXPERIMENTAL

\*) one microperimetric examination with MAIA

Device: MAIA

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.

Main Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: ≥18 years old;
• Best Corrected Visual Acuity (BCVA): ≥ 0.8 Decimal (≥ 20/25 ft, ≤ +0.1 logMAR) at least in the study eye;
• Equivalent spherical refraction between the range ≥ -6D and ≤ +6D; astigmatism within 2D (≤ 2D) at least in the study eye;
• Intraocular Pressure (IOP) ≤ 21 mmHg in both eyes (Goldmann applanation tonometer);
• Clinically normal appearance of the optic nerve head according to clinical judgement (no evidence of excavation, rim thinning, notching, disc hemorrhages, RNFL thinning) in both eyes. This is examined with Spectralis or Solix OCT;
• Clinically normal appearance of the macula according to clinical judgement, in both eyes. This is examined with Spectralis or Solix OCT;
• No ocular pathologies, trauma, surgeries (apart from uncomplicated cataract surgery or peripheral laser retinopexy performed at least 6 months before enrollment) in both eyes;
• Absence of pathologies that can affect visual field in both eyes;
• No use of drugs interfering with the correct execution of perimetry.

You may not qualify if:

• Glaucoma or glaucoma suspect diagnosis in either eye;
• Presence or history of ocular hypertension (IOP ≥ 22 mmHg) in either eye;
• Presence or history of disc hemorrhage in either eye;
• Presence of amblyopia in either eye;
• Nystagmus or poor fixation in either eye;
• Previous laser or any ocular surgery, including uncomplicated cataract surgery performed within 6 months before enrollment in both eyes;
• Any active infection of anterior or posterior segments in the study eye;
• Subjects with significant ocular media opacities preventing acquisition of acceptable infrared (IR) fundus image quality in the study eye;
• Evidence of diabetic retinopathy, diabetic macular edema, or other retinal disease in either eye;
• Use of any drug that can interfere with the correct execution of MP or that would produce visual field loss;
• Unable to tolerate ophthalmic imaging;
• Claustrophobia;
• Inability to provide informed consent.

Sponsors & Collaborators

• Centervue SpA: lead

Study Sites (3)

The Eye Care Institute

Fort Lauderdale, Florida, 33312, United States

NOT YET RECRUITING

UWA Eye Health Centre of Western Australia

Perth, Western Australia, 6009, Australia

NOT YET RECRUITING

Universitätsspital Basel, Augenklinik

Basel, Switzerland, CH-4031, Switzerland

RECRUITING

Study Officials

• Maximilian Pfau, PD Dr. med.

  Universitätsspital Basel, Augenklinik

  STUDY CHAIR

Central Study Contacts

Maximilian Pfau, PD Dr. med.

CONTACT

78 215 42 67; maximilian.pfau@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 25, 2025
• Study Start: April 23, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); CH (1); US (1)