The Role of OCTA in Patients Affected by Beta Thalassemia
February 1, 2021 updated by: Gilda Cennamo, Federico II University
Retinal and Choriocapillaris Vascular Features in Patients With Beta Thalassemia by Means of Optical Coherence Tomography Angiography
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
82
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Naples, Italy, 80100
- University of Naples "Federico II"
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
31 years to 46 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The participans were older than 35 years with diagnosis of Beta Thalassemia.
They did not present other ophthalmological diseases.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with Beta Thalassemia
Patients with previous diagnosis of Beta Thalassemia
|
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
|
Each subject underwent Optical coherence tomography angiography (a non-invasive, fast, diagnostic imaging technique)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Four months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The measurements of retinal structural parameters in patients with Beta Thalassemia, using optical coherence tomography.
Time Frame: Four months
|
The parameters analyzed by optical coherence tomography were: ganglion cell complex and retinal nerve fiber layer
|
Four months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2019
Primary Completion (Actual)
February 25, 2020
Study Completion (Actual)
February 28, 2020
Study Registration Dates
First Submitted
October 3, 2020
First Submitted That Met QC Criteria
October 3, 2020
First Posted (Actual)
October 9, 2020
Study Record Updates
Last Update Posted (Actual)
February 3, 2021
Last Update Submitted That Met QC Criteria
February 1, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1002/19
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.