Optical Coherence Tomography Angiography and Choroidal Osteoma

April 16, 2022 updated by: Gilda Cennamo, Federico II University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Napoli
      • Naples, Napoli, Italy, 80131
        • Federico II University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The participans were older than 50 years with choroidal osteoma. They did not present other ophthalmological diseases.

Description

Inclusion Criteria:

  • age older than 50 years
  • diagnosis of choroidal osteoma
  • absence of history of vitreoretinal and vascular retinal diseases

Exclusion Criteria:

  • age younger than 50 years
  • no diagnosis of choroidal osteoma
  • presence of history of vitreoretinal and vascular retinal diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Investigators

  • Principal Investigator: Gilda Cennamo, Università Federico II

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

January 25, 2022

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

April 16, 2022

First Submitted That Met QC Criteria

April 16, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Actual)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 16, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1604/21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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