Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617001633370
Ethics application status
Approved
Date submitted
16/11/2017
Date registered
15/12/2017
Date last updated
15/12/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Optical coherence tomography angiography in healthy subjects and patients with retinal vascular diseases.
Scientific title
Evaluation of optical coherence tomography angiography parameters in healthy subjects and patients with retinal vascular diseases.
Secondary ID [1] 293384 0
none
Universal Trial Number (UTN)
U1111-1205-2713
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Retinal vascular diseases 305516 0
Condition category
Condition code
Eye 304759 304759 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Optical coherence tomography angiography (OCTA) is a novel imaging technique that enables three dimensional images of retinal and choroidal vasculature.In this study OCTA is performed using the RTVue XR Avanti device (ReVue software, Optovue Inc, Fremont, California, USA) with the Angio Retina mode (3×3 mm ) by experienced technicians. Each OCTA volume is acquired in approximately 3 seconds and 2 orthogonal OCTA volume are acquired to perform motion correction. Retinal images are evaluated and graded for presence and severity of artifacts by two independent examiners using a validated grading system designed by our group . OCTA is done once off visit at the time of diagnosis
Intervention code [1] 299635 0
Diagnosis / Prognosis
Comparator / control treatment
A group of healthy volunteers undergoing optical coherence tomography angiography will be the control group
Control group
Active

Outcomes
Primary outcome [1] 303981 0
To measure the foveal avascular zone (FAZ) area in the superficial retinal vascular plexus using optical coherence tomography angiography (OCTA) in patients with retinal vascular diseases including diabetic retinopathy, retinal vein occlusion and Coats’ disease and in healthy controls
Timepoint [1] 303981 0
OCTA is done as baseline at the diagnosis
Primary outcome [2] 304027 0
To measure the vascular density in the superficial retinal vascular plexus using optical coherence tomography angiography (OCTA) in patients with retinal vascular diseases including diabetic retinopathy, retinal vein occlusion and Coats’ disease and healthy controls
Timepoint [2] 304027 0
OCTA is done as baseline at the diagnosis
Secondary outcome [1] 340626 0
To determine the frequency of motion artifacts in optical coherence tomography angiography images in a group of patients with retinal vascular diseases and healthy controls undergoing routine OCTA imaging;
Timepoint [1] 340626 0
OCTA is done as baseline at the diagnosis
Secondary outcome [2] 340627 0
To explore the differences in profiles of superficial vascular density by using OCTA imaging
Timepoint [2] 340627 0
OCTA is done as baseline at the diagnosis
Secondary outcome [3] 340628 0
To compare the vascular density between the diseased subjects and healthy controls by using OCTA imaging;
Timepoint [3] 340628 0
OCTA is done as baseline at the diagnosis

Eligibility
Key inclusion criteria
Patients with retinal vascular diseases, including diabetic retinopathy, retinal vein occlusion and Coats’ disease, are considered for this study. Both, treatment naïve and previously treated patients are included.and healthy volunteer which are age matched and have no retinal diseases
Minimum age
10 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients with poor image quality with low signal score
Patients with retinal disease other than diabetic retinopathy, retinal vein occlusion and Coats’ disease
healthy volunteer who are not age matched

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
16/01/2015
Date of last participant enrolment
Anticipated
1/06/2018
Actual
Date of last data collection
Anticipated
1/06/2018
Actual
Sample size
Target
300
Accrual to date
150
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 9411 0
Lions Eye Institute Day Surgery Centre - Nedlands
Recruitment postcode(s) [1] 18113 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 298010 0
Hospital
Name [1] 298010 0
Lions Eye Institute
Country [1] 298010 0
Australia
Primary sponsor type
Hospital
Name
lions eye institute
Address
2 Verdun St, Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 297076 0
University
Name [1] 297076 0
Assuit University
Address [1] 297076 0
Markaz El-Fath, Assiut Governorate 71515
Country [1] 297076 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299046 0
Human Ethics Office of Research Enterprise, The University of Western Australia
Ethics committee address [1] 299046 0
Ethics committee country [1] 299046 0
Australia
Date submitted for ethics approval [1] 299046 0
Approval date [1] 299046 0
16/01/2015
Ethics approval number [1] 299046 0
(RA/4/1/7227).

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79102 0
A/Prof Fred K Chen
Address 79102 0
lions eye institute, 2 Verdun St, Nedlands WA 6009
Country 79102 0
Australia
Phone 79102 0
+61 8 9381 0776
Fax 79102 0
+61 8 9381 0700
Email 79102 0
[email protected]
Contact person for public queries
Name 79103 0
Noha Ali
Address 79103 0
lions eye institute, 2 Verdun St, Nedlands WA 6009
Country 79103 0
Australia
Phone 79103 0
+61 403641660
Fax 79103 0
Email 79103 0
[email protected]
Contact person for scientific queries
Name 79104 0
Noha Ali
Address 79104 0
lions eye institute, 2 Verdun St, Nedlands WA 6009
Country 79104 0
Australia
Phone 79104 0
+61 403641660
Fax 79104 0
Email 79104 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.