Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-05-08 @ 2:15 AM
Study NCT ID:
NCT07338461
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-15
First Post:
2025-11-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Resolution Imaging OCT Study
Sponsor:
Heidelberg Engineering GmbH
Organization:
Study Overview
Official Title:
High Resolution Imaging OCT Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
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 goal of this pilot study is to compare image quality between the investigational devices (R1 and HighRes OCT) and the SPECTRALIS (cleared) in adult participants with normal and/or pathology eyes.
Participants will be imaged with different imaging modalities and scan protocols on all study devices.
Participants will be imaged with different imaging modalities and scan protocols on all study devices.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: