Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2026-04-15 @ 3:52 PM
Study NCT ID:
NCT01600261
Status:
COMPLETED
Last Update Posted:
2012-06-28
First Post:
2012-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
iCam Clinical Validation Study
Sponsor:
Optovue
Organization:
Study Overview
Official Title:
iCam Clinical Validation Study
Status:
COMPLETED
Status Verified Date:
2012-06
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:
Comparison study to assess photo image quality of a new color fundus camera compared to that of a commercially available color fundus camera.
Detailed Description:
Optovue has developed a new color fundus camera for imaging the eye with up to 45 degree field of view and without the use of dilating drops. The purpose of the study is to compare the image quality of the new camera with that of a commercially available color fundus camera. Consented subjects will undergo a general ophthalmic examination and series of fundus photography exams using the study device and comparison device. Photo image quality will be assessed for determination of clinically usefulness.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: