Ocular Imaging Study Using Advanced OCT

Macular Degeneration Clinical Trial

Official title:

Ocular Imaging Study Using Advanced OCT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02827071
• Other study ID #: JSEI Nidek Advanced OCT
• Status: Recruiting
• Phase: N/A
• First received: July 6, 2016
• Last updated: July 7, 2016
• Start date: July 2016

Study information

• Verified date: July 2016
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate this AngioScan angiography software on patients with various retinal vascular disorders. The advanced OCT instrument is an FDA approved clinically used camera, but the AngioScan angiography software is not FDA approved. Investigators would like to know if this imaging device and software can improve the quality of images and visualization of imaged tissues and whether they are useful in the diagnosis and treatment of eye diseases. Images collected in this study may be compared to other images collected as part of standard of care on the same patient (OCT, FA, AF, Fundus).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 115 Years

Eligibility

Inclusion Criteria:

• Any patient with abnormal retinal findings as determined by investigators.

Exclusion Criteria:

• Those suffering from head, neck or other injury which makes them unable to position themselves in head restraint for imaging.

• Participants who are unable to maintain retinal fixation on a specified target.

• Participants unable to achieve sufficient pupil dilation and alignment stability for imaging to take place.

• Patients with media opacity which preclude high quality imaging.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Macular Degeneration
• Retinal Vascular Disorder
• Vascular Diseases

Locations

Country	Name	City	State
United States	Stein Eye Institute/Geffen School of Medicine	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal vascular abnormalities imaged by OCT Angiography and en face analysis of macular disorders		2 years	No