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

NCT ID: NCT06071546

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-17
• Study Completion Date: 2024-07-12

Brief Summary

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.

Conditions

Healthy Eyes; Retinal Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Main arm

• 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.

Group Type: EXPERIMENTAL

MAIA

Intervention Type: DEVICE

MAIA is a visual field testing device combining visual field tests, fixation loss correction by a real-time retinal tracker and confocal TrueColor fundus imaging (P/N AHMACME001)

Interventions

MAIA

MAIA is a visual field testing device combining visual field tests, fixation loss correction by a real-time retinal tracker and confocal TrueColor fundus imaging (P/N AHMACME001)

Intervention Type: DEVICE

Eligibility Criteria

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;

• 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

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centervue SpA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maximilian Pfau, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Universitätsspital Basel, Augenklinik

Locations

Universitätsspital Basel, Augenklinik

Basel, , Switzerland

Countries

Switzerland

References

Ansari G, Giudici NL, Cancian G, Rossouw P, Rui C, Rosso A, Gazzina S, Feltgen N, Pfau K, Pfau M. Validation and Repeatability of Differential Light Sensitivity Measurements with the Novel MAIA Microperimetry Device. Ophthalmol Sci. 2025 Jul 16;5(6):100886. doi: 10.1016/j.xops.2025.100886. eCollection 2025 Nov-Dec.

Reference Type: DERIVED

PMID: 40980023 (View on PubMed)

Other Identifiers

MAIA_003_MAG

Identifier Type: -

Identifier Source: org_study_id