Circumscribed Choroidal HaemangiomaNCT04449900
Quantitative Evaluation of Parafoveal Microvasculature Changes in Eyes With Exudative Circumscribed Choroidal Haemangioma: An Optical Coherence Tomography Angiography Study
An observational study of Circumscribed Choroidal Haemangioma and Optical Coherence Tomography Angiography, run by Sun Yat-sen University at 1 site in China.
Trial summary
The study aims to quantitative evaluation of parafoveal microvasculature changes in eyes with exudative circumscribed choroidal haemangioma using optical coherence tomography angiography. Read more about this study
- Who is it for?
- Ages 10 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Circumscribed Choroidal Haemangioma, Optical Coherence Tomography Angiography, Macular
- What is being tested?
- This is observational study with the examination of OCTA
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2017to 30 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
The study aims to quantitative evaluation of parafoveal microvasculature changes in eyes with exudative circumscribed choroidal haemangioma using optical coherence tomography angiography.
Read the 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.
- Being tested
- This is observational study with the examination of OCTA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is observational study with the examination of OCTAOther
This is observational study with the examination of OCTA
| Study group | Role | What they receive |
|---|---|---|
| The exudative CCH group | Treatment naïve patients with exudative CCH which caused subfoveal retinal detachment and/or intraretinal fluid Receives: 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. Receives: Other: This is observational study with the examination of OCTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start1 Mar 2017
- Primary completion30 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circumscribed Choroidal HaemangiomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Chen-jin, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449900
- Sponsor's protocol ID
- 2017MEKY034
- Status last verified
- Jun 2020
- First submitted
- 25 Jun 2020
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Evaluation of Parafoveal Microvasculature Changes in Eyes With Exudative Circumscribed Choroidal Haemangioma: An Optical Coherence Tomography Angiography Study
- ClinicalTrials.gov ID
- NCT04449900
- Acronym / sponsor ID
- 2017MEKY034
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 29 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The exudative CCH group | – | Other: This is observational study with the examination of OCTATreatment naïve patients with exudative CCH which caused subfoveal retinal detachment and/or intraretinal fluid |
| The healthy eye control group | – | Other: This is observational study with the examination of OCTAIn 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. |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is observational study with the examination of OCTAThis is observational study with the examination of OCTA | Other | The exudative CCH group, The healthy eye control group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circumscribed Choroidal Haemangioma and Optical Coherence Tomography Angiography, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative changes of parafoveal microvasculature in eyes with exudative circumscribed choroidal haemangioma (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2020.