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Clinical Trials/NCT04582110
NCT04582110
Completed
Not Applicable

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

Federico II University1 site in 1 country82 target enrollmentOctober 1, 2019
ConditionsThalassemia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thalassemia
Sponsor
Federico II University
Enrollment
82
Locations
1
Primary Endpoint
The measurements of retinal and choriocapillaris features in patients with Beta Thalassemia, using optical coherence tomography angiography.
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2019
End Date
February 28, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Federico II University
Responsible Party
Principal Investigator
Principal Investigator

Gilda Cennamo

Principal Investigator

Federico II University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • The measurements of retinal structural parameters in patients with Beta Thalassemia, using optical coherence tomography.(Four months)

Study Sites (1)

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