OPACITY: Optical Coherence Tomography Angiography (OCT-A) and Central Serous Chorioretinopathy (CSC)

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT03950089

Collaborator

(none)

120

Enrollment

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Central Serous Chorioretinopathy	Device: Optical Coherence Tomography Angiography (OCT-A)

Study Design

Study Type:

Observational

Actual Enrollment :

120 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Optical Coherence Tomography Angiography (OCT-A) Quantitative Assessment of Choriocapillaris Blood Flow in Central Serous Chorioretinopathy (CSC)

Actual Study Start Date :

Jul 1, 2016

Actual Primary Completion Date :

Sep 30, 2017

Actual Study Completion Date :

Sep 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Patients with Central Serous Chorioretinopathy	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.
Healthy patients	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.

Arm

Intervention/Treatment

Patients with Central Serous Chorioretinopathy

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.

Healthy patients

Device: Optical Coherence Tomography Angiography (OCT-A)

Outcome Measures

Primary Outcome Measures

Total number average individual area of flow signal voids [2 months]
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
Total area of flow signal voids [2 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator: Thibaud Mathis, MD, Hospices Civils de Lyon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT03950089

Other Study ID Numbers:

OCTA CSC

First Posted:

May 15, 2019

Last Update Posted:

May 15, 2019

Last Verified:

May 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Central Serous Chorioretinopathy

Study Results

No Results Posted as of May 15, 2019