Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06071546
Status:
COMPLETED
Last Update Posted:
2024-02-07
First Post:
2023-09-22
Brief Title:
Clinical Investigation of a New Version of MAIA Microperimeter on Healthy Subjects and Patients With Retinal Pathology
Sponsor:
Centervue SpA
Organization:
Centervue SpA
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None