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

Primary Purpose

Healthy Eyes, Retinal Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
MAIA
Sponsored by
Centervue SpA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Healthy Eyes

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universitätsspital Basel, Augenklinik

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Main arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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

Full Information

First Posted
September 22, 2023
Last Updated
October 2, 2023
Sponsor
Centervue SpA
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1. Study Identification

Unique Protocol Identification Number
NCT06071546
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
January 15, 2024 (Anticipated)
Study Completion Date
January 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centervue SpA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Eyes, Retinal Diseases

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Main arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
MAIA
Intervention Description
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)
Primary Outcome Measure Information:
Title
To evaluate the limits of agreement between MAIA and MAIA 2013 EDITION for threshold sensitivity values.
Description
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
Time Frame
1 day
Secondary Outcome Measure Information:
Title
To assess the repeatability limits of retinal threshold sensitivity values obtained with MAIA
Description
The acceptance criteria is that the 95% LoA limits for MAIA are at least as narrow as MAIA 2013 EDITION repeatability limits.
Time Frame
1 day
Title
To assess the avoidance of Serious Adverse Device Effects with MAIA
Description
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
Time Frame
through study completion (expected duration: 3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maximilian Pfau, PD Dr. med.
Phone
78 215 42 67
Ext
+41
Email
maximilian.pfau@iob.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Kristina Pfau, PD Dr. med.
Phone
78 480 38 37
Ext
+41
Email
kristina.pfau@usb.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maximilian Pfau, PD Dr. med.
Organizational Affiliation
Universitätsspital Basel, Augenklinik
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsspital Basel, Augenklinik
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maximilian Pfau, PD Dr. med.
Phone
78 215 42 67
Ext
+41
Email
maximilian.pfau@iob.ch
First Name & Middle Initial & Last Name & Degree
Maximilian Pfau, PD Dr. med.

12. IPD Sharing Statement

Plan to Share IPD
No

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

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