NCT03950089

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 15, 2019

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

1.2 years

First QC Date

May 9, 2019

Last Update Submit

May 10, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Patients with Central Serous Chorioretinopathy

Device: Optical Coherence Tomography Angiography (OCT-A)

Healthy patients

Device: Optical Coherence Tomography Angiography (OCT-A)

Interventions

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 patientsPatients with Central Serous Chorioretinopathy

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Thibaud Mathis, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2019

First Posted

May 15, 2019

Study Start

July 1, 2016

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

May 15, 2019

Record last verified: 2019-05