What this study is
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.
What's being tested
- MAIA
Intervention · 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.
Study details
- Official title
- Pre-market Multicentric Cross-sectional Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection
- Sponsor
- Centervue SpA
- Conditions
- Healthy Eyes
- Enrolling
- 380 people
- Starts
- 2025-04-23
- Est. completion
- 2026-06-01
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
3 openThe Eye Care Institute
Fort Lauderdale, Florida, United States
- Julie Rodman, Professor · Contact(954) 262-4274rjulie@nova.edu
- Julie Rodman, Professor · Principal investigator
Not yet recruiting
2 sites outside the US
UWA Eye Health Centre of Western Australia
Perth, Western Australia, Australia
- Allison McKendrick, Professor · Contact8 64887409 ext. +61allison.mckendrick@uwa.edu.au
- Allison McKendrick, Professor · Principal investigator
Not yet recruitingUniversitätsspital Basel, Augenklinik
Basel, Switzerland, Switzerland
- Kristina Pfau, PD Dr. med. · Contact78 480 38 37 ext. +41kristina.pfau@usb.ch
- Kristina Pfau, PD Dr. med. · Principal investigator
- Maximilian Pfau, PD Dr. med. · Sub-investigator
Recruiting
Study team
Sponsor
Centervue SpA
Study ID MAIA_003_MNDB
Study chair
Maximilian Pfau, PD Dr. med.
Universitätsspital Basel, Augenklinik
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.