The Role of OCTA in Patients Affected by Beta Thalassemia

Thalassemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04582110
• Other study ID #: 1002/19
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: February 2021
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: February 28, 2020
• Est. primary completion date: February 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• beta-Thalassemia
• Thalassemia

Intervention

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

Locations

Country	Name	City	State
Italy	University of Naples "Federico II"	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The measurements of retinal and choriocapillaris features in patients with Beta Thalassemia, using optical coherence tomography angiography.	The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillaris vessel density	Four months
Secondary	The measurements of retinal structural parameters in patients with Beta Thalassemia, using optical coherence tomography.	The parameters analyzed by optical coherence tomography were: ganglion cell complex and retinal nerve fiber layer	Four months