NCT04449900

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

March 1, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 29, 2020

Completed
Last Updated

June 29, 2020

Status Verified

June 1, 2020

Enrollment Period

3.2 years

First QC Date

June 25, 2020

Last Update Submit

June 25, 2020

Conditions

Circumscribed Choroidal HaemangiomaOptical Coherence Tomography AngiographyMacular

Outcome Measures

Primary Outcomes (1)

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

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

    3 years

Study Arms (2)

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

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

Interventions

This is observational study with the examination of OCTAOTHER

This is observational study with the examination of OCTA

The exudative CCH groupThe healthy eye control group

Eligibility Criteria

Age10 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

June 25, 2020

First Posted

June 29, 2020

Study Start

March 1, 2017

Primary Completion

May 30, 2020

Study Completion

May 30, 2020

Last Updated

June 29, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)