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OpenTrials
Completed

NCT Number: NCT04582110

The Role of OCTA in Patients Affected by Beta Thalassemia

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

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Key information

Conditions

Thalassemia Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

35 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Naples "Federico II"

Naples, 80100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Optical Coherence tomography angiography

Diagnostic Test

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

Primary outcomes

  1. The measurements of retinal and choriocapillaris features in patients with Beta Thalassemia, using optical coherence tomography angiography.

    Time frame: Four months

    The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillaris vessel density

Secondary outcomes

  1. The measurements of retinal structural parameters in patients with Beta Thalassemia, using optical coherence tomography.

    Time frame: Four months

    The parameters analyzed by optical coherence tomography were: ganglion cell complex and retinal nerve fiber layer

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

Retinal and Choriocapillaris Vascular Features in Patients With Beta Thalassemia by Means of Optical Coherence Tomography Angiography

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 9, 2020
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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