Dark Halo and MNV: a Study Between ICGA and OCTA

NCT ID: NCT05108285

Last Updated: 2021-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-12-15

Brief Summary

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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

Detailed Description

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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

Conditions

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Macular Neovascularisation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MNV group

Eyes affected by MNV. The dark halo of MNV was evaluated by OCTA and ICGA

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

Intervention Type DIAGNOSTIC_TEST

OCTA and ICGA is able to detect the dark halo as a area of reduced perfusion around MVN

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Gilda Cennamo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gilda Cennamo

Role: PRINCIPAL_INVESTIGATOR

Università Federico II

Locations

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University of Naples "Federico II"

Naples, , Italy

Site Status

Countries

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Italy

References

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Fossataro F, Cennamo G, Montorio D, Clemente L, Costagliola C. Dark halo, a new biomarker in macular neovascularization: comparison between OCT angiography and ICGA-a pilot prospective study. Graefes Arch Clin Exp Ophthalmol. 2022 Oct;260(10):3205-3211. doi: 10.1007/s00417-022-05693-8. Epub 2022 May 6.

Reference Type DERIVED
PMID: 35522297 (View on PubMed)

Other Identifiers

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9009/21

Identifier Type: -

Identifier Source: org_study_id