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

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ClinicalTrials.gov Identifier: NCT04449900
Recruitment Status : Completed
First Posted : June 29, 2020
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
Jin Chen-jin, Sun Yat-sen University

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

Condition or disease Intervention/treatment
Circumscribed Choroidal Haemangioma Optical Coherence Tomography Angiography Macular Other: This is observational study with the examination of OCTA

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.

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Study Type : Observational
Actual Enrollment : 82 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Quantitative Evaluation of Parafoveal Microvasculature Changes in Eyes With Exudative Circumscribed Choroidal Haemangioma: An Optical Coherence Tomography Angiography Study
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : May 30, 2020
Actual Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birthmarks

Group/Cohort Intervention/treatment
The exudative CCH group
Treatment naïve patients with exudative CCH which caused subfoveal retinal detachment and/or intraretinal fluid
Other: This is observational study with the examination of OCTA
This is observational study with the examination of OCTA

The healthy eye control group
In the healthy eye control group, all eyes should have no ocular diseases and the best-corrected visual acuity (BCVA) should be 20/20 or better.
Other: This is observational study with the examination of OCTA
This is observational study with the examination of OCTA




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
There are two groups in this study: one is the exudative CCH group,and the other is the healthy eye control group. They performed OCTA at baseline.
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.

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): NCT04449900


Locations
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China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
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Responsible Party: Jin Chen-jin, Prof., Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04449900    
Other Study ID Numbers: 2017MEKY034
First Posted: June 29, 2020    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms