Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection

Official title

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

Overview

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.

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.

Primary outcome measures

• To determine the reference normative values of retinal sensitivity for MAIA [Time frame: 1 day]

Secondary outcome measures (1)

• To assess the avoidance of Serious Adverse Device Effects with MAIA [Time frame: through study completion (expected duration: 10 months)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

United States · 1 center

• The Eye Care Institute — Fort Lauderdale

Australia · 1 center

• UWA Eye Health Centre of Western Australia — Perth

Switzerland · 1 center

• Universitätsspital Basel, Augenklinik — Basel

Identifiers

NCT: NCT06991127 · MAIA_003_MNDB

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗