Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03950089
Recruitment Status : Completed
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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
Central Serous Chorioretinopathy Device: Optical Coherence Tomography Angiography (OCT-A)

Layout table for study information
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 : July 1, 2016
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine


Group/Cohort 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.




Primary Outcome Measures :
  1. Total number average individual area of flow signal voids [ Time Frame: 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

  2. Total area of flow signal voids [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with acute, recurrent or persistent forms of central serous chorioretinopathy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03950089


Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Layout table for investigator information
Principal Investigator: Thibaud Mathis, MD Hospices Civils de Lyon

Layout table for additonal information
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03950089     History of Changes
Other Study ID Numbers: OCTA CSC
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases