The Role of OCTA in Patients Affected by Beta Thalassemia

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Brief Title

The Role of OCTA in Patients Affected by Beta Thalassemia

Official Title

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

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 Type

Observational


Primary Outcome

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

Secondary Outcome

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

Condition

Thalassemia

Intervention

Optical coherence tomography angiography

Study Arms / Comparison Groups

 Patients with Beta Thalassemia
Description:  Patients with previous diagnosis of Beta Thalassemia

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

82

Start Date

October 1, 2019

Completion Date

February 28, 2020

Primary Completion Date

February 25, 2020

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.
      

Gender

All

Ages

35 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT04582110

Organization ID

1002/19


Responsible Party

Principal Investigator

Study Sponsor

Federico II University


Study Sponsor

, , 


Verification Date

February 2021