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Clinical Trials/NCT04449900
NCT04449900
Completed
Not Applicable

Quantitative Evaluation of Parafoveal Microvasculature Changes in Eyes With Exudative Circumscribed Choroidal Haemangioma: An Optical Coherence Tomography Angiography Study

Sun Yat-sen University1 site in 1 country82 target enrollmentMarch 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Circumscribed Choroidal Haemangioma
Sponsor
Sun Yat-sen University
Enrollment
82
Locations
1
Primary Endpoint
Quantitative changes of parafoveal microvasculature in eyes with exudative circumscribed choroidal haemangioma
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The study aims to quantitative evaluation of parafoveal microvasculature changes in eyes with exudative circumscribed choroidal haemangioma using optical coherence tomography angiography.

Detailed Description

Circumscribed choroidal haemangioma (CCH) is an uncommon, potentially congenital benign vascular hamartomas which typically manifests as an elevated mass with reddish-orange pigmentation located posteriorly to the equator, mostly in the macular and peripapillary region. Despite its benign nature, cystoid macular edema (CME) or SRF due to the exudations from the exudative CCH can cause visual impairment. Diagnosis is often suspected clinically, and multimodal imaging is useful for the differential diagnosis of CCH from other malignant tumors such as melanoma. Optical coherence tomography angiography (OCTA) is a rapid, non-invasive, new imaging technology which could provide the capillary density (CD) of superficial and deep capillary plexus as well as the CD of choriocapillaris of the superficial, the latter two of which could not be seen on conventional FA or ICGA. However, little knowledge is known about the parafoveal microvasculature changes in eyes with exudative CCH on OCTA. Therefore, it is necessary to quantitative evaluation of parafoveal microvasculature changes in eyes with exudative CCH compared with healthy eyes without any disease. To the best of our knowledge, this is the first cross-sectional, case-control study to use OCTA to quantitative evaluation of parafoveal microvasculature changes in Eyes with exudative CCH compared with age- and gender-controlled healthy eyes.

Registry
clinicaltrials.gov
Start Date
March 1, 2017
End Date
May 30, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sun Yat-sen University
Responsible Party
Principal Investigator
Principal Investigator

Jin Chen-jin

Prof.

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

  • For patients with exudative CCH, the inclusion criteria were treatment naïve patients with exudative CCH which caused subfoveal retinal detachment and/or intraretinal fluid. For the healthy eye control group, only one eye (randomized by computer) of a subject was included, and the included eyes should have no ocular diseases and the best-corrected visual acuity (BCVA) should be 20/20 or better.

Exclusion Criteria

  • without any other ocular diseases or any severe uncontrolled systemic diseases, including uncontrolled hypertension, coronary heart disease, liver failure, and kidney failure. all the subjects with high diopter \> -6D, long eye axis \> 26.0 mm, or the quality of the acquired OCTA images below 7/10 should be excluded from this study.

Outcomes

Primary Outcomes

Quantitative changes of parafoveal microvasculature in eyes with exudative circumscribed choroidal haemangioma

Time Frame: 3 years

Quantitative changes of parafoveal microvasculature in eyes with exudative circumscribed choroidal haemangioma compared wiyh healthy eyes.

Study Sites (1)

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