Clinical Investigation of a New Version of MAIA Microperimeter on Healthy Subjects and Patients With Retinal Pathology

Centervue

Status: Completed

Conditions: Healthy Eyes; Retinal Diseases

Treatments: Device: MAIA

Study type: Interventional

Funder types: Industry

Identifiers

NCT06071546

MAIA_003_MAG

Details and patient eligibility

About

The purpose of this pre-market, monocentric cross-sectional study is to evaluate the clinical usefulness of a new version of the MAIA device (MAIA) through an agreement with the established version of the MAIA microperimeter (MAIA 2013 EDITION). Moreover, the study aims to evaluate MAIA test-retest repeatability in comparison with MAIA 2013 EDITION and to evaluate MAIA safety and adverse events. These purposes will be achieved by collecting data of healthy subjects and patients with retinal pathology. All participants will undergo repeated microperimetric examinations with both devices during one single visit.

Enrollment: 68 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Healthy Subjects

Inclusion Criteria:

• Age: 18-90 years old;
• BCVA ≥ 0.8 Decimal;
• Equivalent spherical refraction between -12D and +6D; astigmatism within 2D;
• IOP ≤ 21 mmHg;
• Clinically normal appearance of the optic nerve head (examined with Spectralis OCT);
• Clinically normal appearance of the macula (examined with Spectralis OCT);
• No ocular pathologies, trauma, surgeries;
• Absence of pathologies that can affect visual field;
• No use of drugs inferfering with the correct execution of perimetry;

Exclusion Criteria:

• Glaucoma or glaucoma suspect diagnosis;
• IOP ≥ 22 mmHg;
• Presence or history of disc hemorrhage;
• Presence of amblyopia;
• Nystagmus or poor fixation;
• Previous laser or any ocular surgery, including uncomplicated cataract surgery performed within 6 months before enrollment;
• Any active infection of anterior or posterior segments;
• Subjects with significant ocular media opacities;
• Evidence of diabetic retinopathy, diabetic macular edema, or other retinal disease;
• Use of any drug that can interfere with the correct execution of microperimetry or that would produce visual field loss;
• Unable to tolerate ophthalmic imaging;
• Claustrophobia;
• Inability to provide informed consent.

Patients with retinal pathology

Inclusion Criteria:

• Age: 18-90 years old;
• BCVA ≥ 0.1 Decimal;
• Equivalent spherical refraction between -12D and +6D; astigmatism within 2D;
• Diagnosis of any type of retinal disease by investigator based on fundoscopy and Spectralis OCT for which microperimetry is indicated;

Exclusion Criteria:

• Any ocular surgery, with the exception of uncomplicated cataract surgery performed at least 6 months before enrollment;
• Subjects unable to tolerate ophthalmic imaging;
• Nystagmus;
• Subjects with significant ocular media opacities;
• Use of any drug that can interfere with the correct execution of microperimetry or that would produce visual field loss;
• Claustrophobia;
• Inability to provide informed consent;
• Vulnerable subjects according to the investigator's judgement.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

68 participants in 1 patient group

Main arm

Experimental group

Description:

* one microperimetric examination with MAIA, one microperimetric examination with MAIA 2013 EDITION for agreement evaluation; * one additional microperimetric examination with MAIA and one additional microperimetric examination with MAIA 2013 EDITION for repetability evaluation.

Treatment:

Device: MAIA