SD-OCT Angiography

NCT02510885 | Terminated Results

• 1 other identifier: Pro00063777
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to image retinal vascular alterations in patients with retinal disease using the AngioVue OCT-A system and understand the information these images provide. The investigators will image study participants who have retinal diseases with the AngioVue unit (Optovue) and will collect relevant clinical data to understand the nature of the information contained in images obtained on AngioVue. This study being conducted under an abbreviated IDE. The investigators will analyze data using descriptive statistics. Risks related to light exposure will be managed by ensuring that the exposure to the AngioVue light source is well below maximum permissible limits for safe exposure.

Conditions

Neovascular Age-related Macular Degeneration; Age-related Macular Degeneration; Diabetic Retinopathy; Retinal Vein Occlusion; Diabetic Macular Edema

Keywords

neovascular age-related macular degeneration; age-related macular degeneration; diabetic retinopathy; SD-OCT; Angiography; diabetic macular edema

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Image Quality Sensitive Enough to Identify Specific New Vessel Morphology

  Day 0

Study Arms (1)

SD-OCT Angiography

EXPERIMENTAL

Study participants will undergo imaging of both eyes with the AngioVue unit (approximately 60 seconds/eye), per standard operating protocol. Imaging is noncontact, and pharmacologic dilation will not be used for the purposes of this study. In most instances, study participants will undergo only a single imaging session on a single day. However, potential participants will be asked to consent for additional imaging sessions (up to 12) that may occur over the course of subsequent future visits to the clinic. Additionally, study participants will be asked to consent to prospective collection of clinical and demographic data, to correlate findings of OCT-A imaging to subsequent clinical course.

Device: AngioVue SD-OCT

Interventions

AngioVue SD-OCT DEVICE

OCT-A allows noninvasive, high-resolution imaging of the microvasculature of the retina and choroid, without intravenous dye administration. SD-OCT units use the light source used in commercially available and FDA-cleared OCT units on a modified platform. Optovue, Inc. has developed a customized SD-OCT system that implements a novel algorithm, the amplitude-based method of split-spectrum amplitude-decorrelation angiography (SSADA) for OCT-A. This detects motion in the blood vessel lumen by measuring the variation in reflected OCT signal amplitude between consecutive cross-sectional scans. Optovue has integrated the novel SSADA algorithm into their commercially approved RTVue SD-OCT unit for their OCT-A unit, the AngioVue. This unit is being conducted under an abbreviated IDE.

SD-OCT Angiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capable and willing to provide consent
• History of clinically diagnosed retinal diseases, including but not limited to age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, macular telangiectasias, and diabetic macular edema
• At least 18 years of age

You may not qualify if:

• Unable or unwilling to give consent
• Under 18 years of age

Sponsors & Collaborators

• Duke University: lead
• Optovue: collaborator

Study Sites (1)

Duke Eye Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Diabetic Retinopathy; Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis

Results Point of Contact

• Title: Dr. Priyatham Mettu
• Organization: Duke Eye Center

priyatham.mettu@duke.edu

919-684-9010

Study Officials

• Priyatham Mettu, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: July 29, 2015
• Study Start: July 1, 2015
• Primary Completion: March 11, 2019
• Study Completion: March 11, 2019
• Last Updated: April 19, 2022
• Results First Posted: April 19, 2022

Record last verified: 2022-03

Locations

US (1)