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The Role of OCTA in Patients Affected by Beta Thalassemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04582110
Recruitment Status : Completed
First Posted : October 9, 2020
Last Update Posted : October 9, 2020
Sponsor:
Information provided by (Responsible Party):
Gilda Cennamo, Federico II University

Tracking Information
First Submitted Date October 3, 2020
First Posted Date October 9, 2020
Last Update Posted Date October 9, 2020
Actual Study Start Date October 1, 2019
Actual Primary Completion Date February 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 3, 2020)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: October 3, 2020)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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 Talassemia. 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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Thalassemia
Intervention Diagnostic Test: Optical coherence tomography angiography
Each subject underwent Optical coherence tomography angiography (a non-invasive, fast, diagnostic imaging technique)
Study Groups/Cohorts
  • Patients with Beta Thalassemia
    Patients with previous diagnosis of Beta Thalassemia
    Intervention: Diagnostic Test: Optical coherence tomography angiography
  • Control Group
    Healthy fellow eyes without actual and previous ocular trauma
    Intervention: Diagnostic Test: Optical coherence tomography angiography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 3, 2020)
82
Original Actual Enrollment Same as current
Actual Study Completion Date February 28, 2020
Actual Primary Completion Date February 25, 2020   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 35 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04582110
Other Study ID Numbers 1002/19
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Gilda Cennamo, Federico II University
Study Sponsor Federico II University
Collaborators Not Provided
Investigators Not Provided
PRS Account Federico II University
Verification Date October 2020