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NCT Number: NCT06991127

Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection

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.

Recruiting

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Key information

Conditions

Healthy Eyes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UWA Eye Health Centre of Western Australia, Perth, Western Australia, Australia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. To determine the reference normative values of retinal sensitivity for MAIA

    Time frame: 1 day

    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

Secondary outcomes

  1. To assess the avoidance of Serious Adverse Device Effects with MAIA

    Time frame: through study completion (expected duration: 10 months)

    During the clinical investigation, adverse events will be documented, investigated and reported according to the provisions of applicable reporting guidelines, following their criteria and timelines.

Study contacts

Contact information is provided by the study sponsor or research team.

Maximilian Pfau, PD Dr. med.

CONTACT

[email protected]

78 215 42 67 ext. +41

Sponsors and collaborators

Lead sponsor

Centervue SpA

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 25, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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