The Role of OCTA in Patients Affected by Beta Thalassemia

Sponsor

Federico II University (Other)

Overall Status

Completed

CT.gov ID

NCT04582110

Collaborator

(none)

Enrollment

Location

4.9

Actual Duration (Months)

16.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Thalassemia	Diagnostic Test: Optical coherence tomography angiography

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 Design

Study Type:

Observational

Actual Enrollment :

82 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2019

Actual Primary Completion Date :

Feb 25, 2020

Actual Study Completion Date :

Feb 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
Patients with Beta Thalassemia Patients with previous diagnosis of Beta Thalassemia	Diagnostic Test: Optical coherence tomography angiography Each subject underwent Optical coherence tomography angiography (a non-invasive, fast, diagnostic imaging technique)
Control Group Healthy fellow eyes without actual and previous ocular trauma	Diagnostic Test: Optical coherence tomography angiography Each subject underwent Optical coherence tomography angiography (a non-invasive, fast, diagnostic imaging technique)

Arm

Intervention/Treatment

Patients with Beta Thalassemia

Patients with previous diagnosis of Beta Thalassemia

Diagnostic Test: Optical coherence tomography angiography

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

Control Group

Healthy fellow eyes without actual and previous ocular trauma

Diagnostic Test: Optical coherence tomography angiography

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Naples "Federico II"	Naples		Italy	80100

Sponsors and Collaborators

Federico II University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gilda Cennamo, Principal Investigator, Federico II University

ClinicalTrials.gov Identifier:

NCT04582110

Other Study ID Numbers:

1002/19

First Posted:

Oct 9, 2020

Last Update Posted:

Feb 3, 2021

Last Verified:

Feb 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Thalassemia

beta-Thalassemia

Study Results

No Results Posted as of Feb 3, 2021