Actively Recruiting
Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection
Led by Centervue SpA · Updated on 2025-05-25
380
Participants Needed
3
Research Sites
57 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Best corrected visual acuity (BCVA) of at least 0.8 decimal (20/25 ft, 0.1 logMAR) in the study eye
- Equivalent spherical refraction between -6D and +6D; astigmatism 2D in the study eye
- Intraocular pressure (IOP) 21 mmHg in both eyes
- Clinically normal optic nerve head appearance in both eyes, assessed with OCT
- Clinically normal macula appearance in both eyes, assessed with OCT
- No ocular pathologies, trauma, or surgeries (except uncomplicated cataract surgery or peripheral laser retinopexy performed at least 6 months before enrollment) in both eyes
- No pathologies affecting visual field in both eyes
- No use of drugs interfering with perimetry execution
You will not qualify if you...
- Diagnosis of glaucoma or glaucoma suspect in either eye
- History or presence of ocular hypertension (IOP 22 mmHg) in either eye
- History or presence 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 within 6 months before enrollment in both eyes
- Active infection of anterior or posterior eye segments in the study eye
- Significant ocular media opacities preventing acceptable infrared fundus image quality in the study eye
- Evidence of diabetic retinopathy, diabetic macular edema, or other retinal diseases in either eye
- Use of drugs interfering with microperimetry or causing visual field loss
- Inability to tolerate ophthalmic imaging
- Claustrophobia
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
The Eye Care Institute
Fort Lauderdale, Florida, United States, 33312
Not Yet Recruiting
2
UWA Eye Health Centre of Western Australia
Perth, Western Australia, Australia, 6009
Not Yet Recruiting
3
Universitätsspital Basel, Augenklinik
Basel, Switzerland, Switzerland, CH-4031
Actively Recruiting
Research Team
M
Maximilian Pfau, PD Dr. med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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