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

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.