Dark Halo and MNV: a Study Between ICGA and OCTA

Sponsor
Federico II University (Other)
Overall Status
Completed
CT.gov ID
NCT05108285
Collaborator
(none)
50
1
35.4
1.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Optical Coherence Tomography Angiography (OCTA) and indocyanine green angiography (ICGA)

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 Design

Study Type:
Observational
Actual Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Dark Halo a New Biomarker in Macular Neovascularization: a Comparative Study Between ICGA and OCTA
Actual Study Start Date :
Jan 1, 2018
Actual Primary Completion Date :
Dec 1, 2020
Actual Study Completion Date :
Dec 15, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Dark halo measurement [three years]

    The OCTA and ICGA parameters analyzed are: the area of dark halo (mm2) that surrounds the coroidal neovascularization.

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Naples "Federico II" Naples Italy 80100

Sponsors and Collaborators

  • Federico II University

Investigators

  • Principal Investigator: Gilda Cennamo, Università Federico II

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gilda Cennamo, Principal Investigator, Federico II University
ClinicalTrials.gov Identifier:
NCT05108285
Other Study ID Numbers:
  • 9009/21
First Posted:
Nov 4, 2021
Last Update Posted:
Nov 17, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 17, 2021