Creating a database for the MAIA Microperimeter Device using healthy eyes
Official title: Pre-market Multicentric Cross-sectional Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection
Run by Centervue SpA · NCT06991127 · Data updated 2026-11-12
This study is testing the MAIA Microperimeter Device by collecting information from people with healthy eyes to create a standard database that shows how the device works in low-light conditions.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 380 (estimated) |
| Sponsor | Centervue SpA Industry-sponsored |
| Locations | 3 sites (Fort Lauderdale, Florida and 2 other locations) |
| Status | Recruiting |
| Started | April 23, 2025 |
| Main results expected | May 1, 2026 |
| Study ends | June 1, 2026 |
| Registry record updated | May 25, 2025 |
| Trial ID | NCT06991127 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are healthy adults aged 18 and older with specific visual acuity and refractive criteria.
✕Probably not a fit
Patients with ocular pathologies, previous eye surgeries (except uncomplicated cataract surgery), or those with significant refractive errors may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical investigation aims to establish a normative database for the MAIA Microperimeter Device by collecting data from healthy subjects. Participants will undergo microperimetric examinations in a single visit to evaluate the device's safety and any adverse events. The study is multicentric and focuses on individuals with clinically normal eyes to ensure accurate baseline measurements. The data collected will help in understanding the device's performance in mesopic conditions.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of visual field assessments in mesopic conditions, leading to improved diagnostic capabilities.
How similar studies have gone: While this approach is focused on creating a normative database, similar studies using microperimetry have shown promise in enhancing visual field assessments.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Universitätsspital Basel, Augenklinik
Basel, Switzerland, Switzerland Recruiting -
The Eye Care Institute
Fort Lauderdale, Florida, United States Not yet recruiting -
UWA Eye Health Centre of Western Australia
Perth, Western Australia, Australia Not yet recruiting
Study contacts
- Study coordinator: Maximilian Pfau, PD Dr. med.
- Email: maximilian.pfau@usb.ch
- Phone: 78 215 42 67
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.