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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03950089
Other study ID # OCTA CSC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2016
Est. completion date September 30, 2017

Study information

Verified date May 2019
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Optical Coherence Tomography Angiography (OCT-A) is a noninvasive imaging technique that allows one to see blood vessels in the retina. The investigating team used this approach in patients with acute, recurrent and persistent subtypes of Central Serous Chorioretinopathy (CSC) to check for possible Choriocapillaris hypoperfusion. The presence or absence of these microvascular changes was explored in both eyes of the patients and compared to a control group of healthy volunteers. The possibility of a correlation between Choriocapillaris flow deficits, age and spontaneous resolution of serous retinal detachment was also evaluated. This study was conducted in an effort to improve one's understanding of this disease and other pachychoroid disorders.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date September 30, 2017
Est. primary completion date September 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with acute, recurrent or persistent forms of central serous chorioretinopathy

Exclusion Criteria:

- Patients with chronic central serous chorioretinopathy were not eligible for inclusion

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Optical Coherence Tomography Angiography (OCT-A)
Optical Coherence Tomography Angiography (OCT-A) images were acquired using an Spectral Domain Optical Coherence Tomography device (Cirrus High Definition OCT Model 5000 with Angioplex; Carl Zeiss Meditec, Dublin, California, USA). With an acquisition speed of 68,000 A-Scan per second, the OCT Microangiography Complex algorithm provided OCT-A information for three-dimensional (3D) flow reconstruction. At each visit, each subject underwent a 3 x 3 millimeter (mm) macular 3D cube acquisition in both eyes. FastTrac continuous eye tracking technology was employed to control for eye movements and minimize motion artefacts.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Outcome

Type Measure Description Time frame Safety issue
Primary Total number average individual area of flow signal voids 3x3 Optical Coherence Tomography Angiography (OCT-A) images on choriocapillaris slab were exported from the Angioplex software and then imported into the open-source Fiji software. Each image was binarized in black and white pixels. Thresholded areas greater than or equal to 1 white pixel were considered as flow signal voids 2 months
Primary Total area of flow signal voids 3x3 Optical Coherence Tomography Angiography (OCT-A) images on choriocapillaris slab were exported from the Angioplex software and then imported into the open-source Fiji software. Each image was binarized in black and white pixels. Thresholded areas greater than or equal to 1 white pixel were considered as flow signal voids 2 months
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