The Role of OCTA in Patients Affected by Beta Thalassemia

• ClinicalTrials.gov Identifier: NCT04582110
• Recruitment Status: Completed
• First Posted: October 9, 2020
• Last Update Posted: October 9, 2020
• Sponsor: Federico II University
• 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

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

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