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

Study Overview
=================
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.

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

Conditions
-----------------
Healthy Eyes, Retinal Diseases

Intervention / Treatment
-----------------
* Device: MAIA


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Main arm<br>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<br>* 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)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. Bland JM, Altman DG (1986) Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1(8476):307-10. Bland JM, Altman DG (1999) Measuring agreement in method comparison studies. Statistical Methods in Medical Research 8:135-160 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the repeatability limits of retinal threshold sensitivity values obtained with MAIA | The acceptance criteria is that the 95% LoA limits for MAIA are at least as narrow as MAIA 2013 EDITION repeatability limits. | 1 day | 
| To assess the avoidance of Serious Adverse Device Effects with MAIA | During the clinical investigation, adverse events will be documented, investigated and reported according to the provisions of applicable reporting guidelines, following their criteria and timelines | through study completion (expected duration: 3 months) |