Choroidal Osteoma, BilateralNCT05342324
Optical Coherence Tomography Angiography and Choroidal Osteoma
An observational study of Choroidal Osteoma, Bilateral, run by Federico II University at 1 site in Italy.
Trial summary
This study evaluates the vessel density of choriocapillary vascular network in eyes affected by choroidal osteoma and in eyes complicated by choroidal neovascularization, using optical coherence tomography angiography. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Choroidal Osteoma, Bilateral
- What is being tested?
- Optical coherence tomography angiography
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2015to 31 Jan 2022
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participans were older than 50 years with choroidal osteoma. They did not present other ophthalmological diseases.
Who may be able to join
- age older than 50 years
- diagnosis of choroidal osteoma
- absence of history of vitreoretinal and vascular retinal diseases
Who cannot join
- age younger than 50 years
- no diagnosis of choroidal osteoma
- presence of history of vitreoretinal and vascular retinal diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optical Coherence Tomography Angiography in Choroidal Osteoma: a Quantitative Evaluation of Choriocapillary Vessel Density
This study evaluates the vessel density of choriocapillary vascular network in eyes affected by choroidal osteoma and in eyes complicated by choroidal neovascularization, using optical coherence tomography angiography.
Read the detailed description
The choroidal osteoma is a rare benign tumor of choroid, it is bilateral in 10%-25% of cases, affecting usually young women. Previous studies evaluated the morphologic characteristics of tumor-related vasculatures, described as a seafun vascular networks, but none focused on study of vessel density of coriocapillary.
The aim of this study is to investigate the potential role of the optical coherence tomography angiography (OCTA) in evaluating the choriocapillary vessel density in order to individuate the changes of this vascular network that may influence the onset of choroidal neovasculariztion.
Therefore, OCTA could be useful in the clinical management of the choroidal osteoma
- Conditions
- Choroidal Osteoma, Bilateral
- Being tested
- Optical coherence tomography angiography
- Medical subject headings
- Choroidal Osteoma, Bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomography angiographyDiagnostic test
To evaluate the vessel density in choriocapillary vascular networks, using optical coherence tomography angiography
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of vessel density of the choriocapillary in patients affected by choroidal osteoma .
To evaluate the role of optical coherence tomography angiography in evaluating the features of the choriocapillary, using optical coherence tomography angiography (OCTA) in patients with choroidal osteoma and in patients with choroidal osteoma complicated by choroidal neovascularization. The parameter analyzed by OCTA was the vessel density of choriocapillary (percent)
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Jun 2015
- Primary completion25 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Choroidal Osteoma, BilateralStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilda Cennamo, Federico II University
- Investigators
- Gilda Cennamo, Principal investigator, Università Federico II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342324
- Sponsor's protocol ID
- 1604/21
- Status last verified
- Apr 2022
- First submitted
- 16 Apr 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cennamo G, Iacucci G, Breve MA, Montorio D, Xompero C, Costagliola C. The role of choriocapillaris vessel density in the pathogenesis of macular neovascularization associated with choroidal osteoma. Graefes Arch Clin Exp Ophthalmol. 2023 May;261(5):1283-1287. doi: 10.1007/s00417-022-05921-1. Epub 2022 Dec 1.
PubMed 36454322
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Angiography in Choroidal Osteoma: a Quantitative Evaluation of Choriocapillary Vessel Density
- ClinicalTrials.gov ID
- NCT05342324
- Acronym / sponsor ID
- 1604/21
- Conditions
- Choroidal Osteoma, Bilateral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 22 Apr 2022 (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.
This study evaluates the vessel density of choriocapillary vascular network in eyes affected by choroidal osteoma and in eyes complicated by choroidal neovascularization, using optical coherence tomography angiography.
Detailed description
The choroidal osteoma is a rare benign tumor of choroid, it is bilateral in 10%-25% of cases, affecting usually young women. Previous studies evaluated the morphologic characteristics of tumor-related vasculatures, described as a seafun vascular networks, but none focused on study of vessel density of coriocapillary.
The aim of this study is to investigate the potential role of the optical coherence tomography angiography (OCTA) in evaluating the choriocapillary vessel density in order to individuate the changes of this vascular network that may influence the onset of choroidal neovasculariztion.
Therefore, OCTA could be useful in the clinical management of the choroidal osteoma
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participans were older than 50 years with choroidal osteoma. They did not present other ophthalmological diseases.
Key inclusion criteria (3 listed)
- age older than 50 years
- diagnosis of choroidal osteoma
- absence of history of vitreoretinal and vascular retinal diseases
Key exclusion criteria (3 listed)
- age younger than 50 years
- no diagnosis of choroidal osteoma
- presence of history of vitreoretinal and vascular retinal diseases
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 |
|---|---|---|
| Optical coherence tomography angiographyTo evaluate the vessel density in choriocapillary vascular networks, using optical coherence tomography angiography | Diagnostic test | – |
Primary outcome
Study of vessel density of the choriocapillary in patients affected by choroidal osteoma .
Time frame: 7 years
To evaluate the role of optical coherence tomography angiography in evaluating the features of the choriocapillary, using optical coherence tomography angiography (OCTA) in patients with choroidal osteoma and in patients with choroidal osteoma complicated by choroidal neovascularization. The parameter analyzed by OCTA was the vessel density of choriocapillary (percent)
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 22 Apr 2022.
- Derived from this study: PubMed 36454322Cennamo G, Iacucci G, Breve MA, Montorio D, Xompero C, Costagliola C. The role of choriocapillaris vessel density in the pathogenesis of macular neovascularization associated with choroidal osteoma. Graefes Arch Clin Exp Ophthalmol. 2023 May;261(5):1283-1287. doi: 10.1007/s00417-022-05921-1. Epub 2022 Dec 1.
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.
Gilda Cennamo principal investigator
Università Federico II
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 Choroidal Osteoma, Bilateral, run by Federico II University at 1 site in Italy.
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 3 inclusion and 3 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 22 Apr 2022. 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 Italy. 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?
Study of vessel density of the choriocapillary in patients affected by choroidal osteoma . (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05342324, which also lists 1 linked publication.
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 22 Apr 2022.