Clinical Investigation of MAIA Microperimeter Device: Mes... | NCT06991127

NCT06991127

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Main Arm	Experimental	*) one microperimetric examination with MAIA	Device: MAIA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MAIA	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the reference normative values of retinal sensitivity for MAIA	The reference normative values will be determined by using a linear regression model for Mean Sensitivity (MS) as a function of age. The 5th and 10th percentile values will be derived for each age, and will serve as age-adjusted normative data against which compare the MS computed during each test with MAIA	1 day

Secondary Outcomes

Measure	Description	Time Frame
To assess the avoidance of Serious Adverse Device Effects with MAIA	During the clinical investigation, adverse events will be documented, investigated and reported according to the provisions of applicable reporting guidelines, following their criteria and timelines.	through study completion (expected duration: 10 months)

Eligibility Module

Eligibility 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.