Status:
RECRUITING
Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection
Lead Sponsor:
Centervue SpA
Conditions:
Healthy Eyes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT06991127
Start Date
April 23 2025
End Date
June 1 2026
Last Update
May 25 2025
Active Locations (3)
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1
The Eye Care Institute
Fort Lauderdale, Florida, United States, 33312
2
UWA Eye Health Centre of Western Australia
Perth, Western Australia, Australia, 6009
3
Universitätsspital Basel, Augenklinik
Basel, Switzerland, Switzerland, CH-4031