Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection
ConditionHealthy Eyes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentervue SpA
About this trial
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.
Eligibility criteria
Qualifiers
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);
Disqualifiers
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;
Trial design
Treatments tested in this trial
- MAIA
Treatment groups
380 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov