The Role of OCTA in Patients Affected by Beta Thalassemia

NCT ID: NCT04582110

Last Updated: 2021-02-03

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

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-02-28

Brief Summary

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To investigate, using optical coherence tomography angiography (OCTA), the retinal and choriocapillaris vascular features in patients affected by Beta Thalassemia. Moreover we analyzed the structural retinal parameters (ganglion cell complex and retinal nerve fiber layer), using optical coherence tomography (OCT) in these patients

Detailed Description

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Beta Thalassemia is one of the most common genetic hemoglobinopathy characterized by a defective β globulin chain synthesis leading to hemolysis and ineffective erythropoiesis.

The study investigated the changes in retinal and choriocapillaris vascular features using optical coherence tomography angiography, a novel and noninvasive diagnostic technique that allows a detailed analysis of retinal and choriocapillaris blood flow.

Conditions

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Thalassemia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Beta Thalassemia

Patients with previous diagnosis of Beta Thalassemia

Optical coherence tomography angiography

Intervention Type DIAGNOSTIC_TEST

Each subject underwent Optical coherence tomography angiography (a non-invasive, fast, diagnostic imaging technique)

Control Group

Healthy fellow eyes without actual and previous ocular trauma

Optical coherence tomography angiography

Intervention Type DIAGNOSTIC_TEST

Each subject underwent Optical coherence tomography angiography (a non-invasive, fast, diagnostic imaging technique)

Interventions

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Optical coherence tomography angiography

Each subject underwent Optical coherence tomography angiography (a non-invasive, fast, diagnostic imaging technique)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* age older than 35 years
* diagnosis of Beta Thalassemia
* absence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
* absence of significant lens opacities, low-quality OCT and OCT-A images.

Exclusion Criteria

* age older than 50 years
* absence of diagnosis of Beta Thalassemia
* presence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
* presence of significant lens opacities, low-quality OCT and OCT-A images.
Minimum Eligible Age

35 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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

Locations

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University of Naples "Federico II"

Naples, , Italy

Site Status

Countries

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Italy

Other Identifiers

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1002/19

Identifier Type: -

Identifier Source: org_study_id

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