The Role of OCTA in Patients Affected by Beta Thalassemia

Completed

• Conditions: Thalassemia
• Interventions: Diagnostic Test: Optical coherence tomography angiography

• Registration Number: NCT04582110
• Lead Sponsor: Federico II University

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2019-10-01
• Primary Completion: 2020-02-25
• Study Completion: 2020-02-28
• Study First Submitted: 2020-10-03
• Study First Submitted QC: 2020-10-03
• Study First Posted: 2020-10-09
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Group	Optical coherence tomography angiography	Healthy fellow eyes without actual and previous ocular trauma
Patients with Beta Thalassemia	Optical coherence tomography angiography	Patients with previous diagnosis of Beta Thalassemia

Primary Outcome Measures

Name	Time	Method
The measurements of retinal and choriocapillaris features in patients with Beta Thalassemia, using optical coherence tomography angiography.	Four months	The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillaris vessel density

Secondary Outcome Measures

Name	Time	Method
The measurements of retinal structural parameters in patients with Beta Thalassemia, using optical coherence tomography.	Four months	The parameters analyzed by optical coherence tomography were: ganglion cell complex and retinal nerve fiber layer

Trial Locations

Locations (1)

University of Naples "Federico II"; 🇮🇹 Naples, Italy