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

NCT06071546 | Completed

• 1 other identifier: MAIA_003_MAG
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• To evaluate the limits of agreement between MAIA and MAIA 2013 EDITION for threshold sensitivity values.

  Agreement will be quantified by using the method proposed by Bland and Altman \[1,2,3\], estimating the 95%-Limits of Agreement (LoA) of the difference of threshold sensitivity values. The acceptance criteria for agreement between MAIA and MAIA 2013 EDITION is that MAIA's 95% LoA limits are within MAIA 2013 EDITION repeatability limits. 1. Bland JM, Altman DG (1986) Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1(8476):307-10. 2. Bland JM, Altman DG (1999) Measuring agreement in method comparison studies. Statistical Methods in Medical Research 8:135-160 3. Bland JM, Altman DG (2007), Agreement Between Methods of Measurement with Multiple Observations Per Individual, Journal of Biopharmaceutical Statistics 17:571-82

  1 day

Secondary Outcomes (2)

• To assess the repeatability limits of retinal threshold sensitivity values obtained with MAIA

  1 day

• To assess the avoidance of Serious Adverse Device Effects with MAIA

  through study completion (expected duration: 3 months)

Study Arms (1)

Main arm

EXPERIMENTAL

* 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.

Device: MAIA

Interventions

MAIA 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)

Main arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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
• Age: 18-90 years old;

Sponsors & Collaborators

• Centervue SpA: lead

Study Sites (1)

Universitätsspital Basel, Augenklinik

Basel, CH-4031, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 40980023 DERIVED

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Maximilian Pfau, PD Dr. med.

  Universitätsspital Basel, Augenklinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: October 6, 2023
• Study Start: October 17, 2023
• Primary Completion: July 12, 2024
• Study Completion: July 12, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)