Clinical trial NCT06071546: Clinical Investigation of a New Version of MAIA Microperimeter on Healthy Subjects and Patients With Retinal Pathology
Official title: Pre-market Monocentric Cross-sectional Clinical Investigation of MAIA on Healthy Subjects and Patients With Retinal Pathology: Agreement With MAIA 2013 EDITION Microperimeter and Repeatability Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Eyes
Retinal Diseases
Lead sponsor: Centervue SpA
Sponsor class: INDUSTRY
First posted: 2023-10-06
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: To evaluate the limits of agreement between MAIA and MAIA 2013 EDITION for threshold sensitivity values.
timeFrame: 1 day
Secondary outcomes:
measure: To assess the repeatability limits of retinal threshold sensitivity values obtained with MAIA
timeFrame: 1 day
measure: To assess the avoidance of Serious Adverse Device Effects with MAIA
timeFrame: through study completion (expected duration: 3 months)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitätsspital Basel, Augenklinik
Study officials:
affiliation: Universitätsspital Basel, Augenklinik
name: Maximilian Pfau, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: