Dark Halo and MNV: a Study Between ICGA and OCTA

November 16, 2021 updated by: Gilda Cennamo, Federico II University

Dark Halo a New Biomarker in Macular Neovascularization: a Comparative Study Between ICGA and OCTA

The aim of study is to compare the evaluation of dark halo area of macular neovascularization (MNV) between indocyanine green angiography (ICGA) and optical coherence tomography angiography (OCTA) in order to identify OCTA as effective and useful biomarker in MNV

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dark halo is defined as a dark perilesional of flow decrease due to an area of reduced choroidal flow adjacent to the macular neovascularization (MNV).

The detection of MNV vascular details was only possible through invasive dye injection, such as fluorescein angiography (FA) or indocyanine green angiography (ICGA).

Optical coherence tomography angiography (OCTA) is a recent imaging technique that is able to detect the perfusion and non-perfusion areas carefully.

The aim of study is to compare the evaluation of dark halo area of MNV between ICGA and OCTA

Study Type

Observational

Enrollment (Actual)

50

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
      • Naples, Italy, 80100
        • University of Naples "Federico II"

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

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A group of patients affected by MNV is subjected to OCTA and ICGA analysis in order to evaluate which of two methods is able to detect in a peculiar way the dark halo around the MNV

Description

Inclusion Criteria:

  • age older than 55 years
  • diagnosis of macular neovascularization
  • absence of previous treatment with anti-Vegf injections
  • absence of other retinal vascular diseases

Exclusion Criteria:

  • age younger than 55 years
  • absence diagnosis of macular neovascularization
  • presence of previous treatment with anti-Vegf injections
  • presence of other retinal vascular 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MNV group
Eyes affected by MNV. The dark halo of MNV was evaluated by OCTA and ICGA
Diagnostic test: Optical Coherence Tomography Angiography (OCTA) and indocyanine green angiography (ICGA)
OCTA and ICGA is able to detect the dark halo as a area of reduced perfusion around MVN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dark halo measurement
Time Frame: three years
The OCTA and ICGA parameters analyzed are: the area of dark halo (mm2) that surrounds the coroidal neovascularization.
three 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2018

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 15, 2020

Study Registration Dates

First Submitted

October 24, 2021

First Submitted That Met QC Criteria

November 3, 2021

First Posted (Actual)

November 4, 2021

Study Record Updates

Last Update Posted (Actual)

November 17, 2021

Last Update Submitted That Met QC Criteria

November 16, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9009/21

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.

Clinical Trials on Macular Neovascularisation

Clinical Trials on Optical Coherence Tomography Angiography (OCTA) and indocyanine green angiography (ICGA)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe