The Role of OCTA in Patients Affected by Beta Thalassemia
Retinal and Choriocapillaris Vascular Features in Patients With Beta Thalassemia by Means of Optical Coherence Tomography Angiography
1 other identifier
observational
82
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2020
CompletedFirst Submitted
Initial submission to the registry
October 3, 2020
CompletedFirst Posted
Study publicly available on registry
October 9, 2020
CompletedFebruary 3, 2021
February 1, 2021
5 months
October 3, 2020
February 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
The measurements of retinal and choriocapillaris features in patients with Beta Thalassemia, using optical coherence tomography angiography.
The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillaris vessel density
Four months
Secondary Outcomes (1)
The measurements of retinal structural parameters in patients with Beta Thalassemia, using optical coherence tomography.
Four months
Study Arms (2)
Patients with Beta Thalassemia
Patients with previous diagnosis of Beta Thalassemia
Control Group
Healthy fellow eyes without actual and previous ocular trauma
Interventions
Each subject underwent Optical coherence tomography angiography (a non-invasive, fast, diagnostic imaging technique)
Eligibility Criteria
The participans were older than 35 years with diagnosis of Beta Thalassemia. They did not present other ophthalmological diseases.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Naples "Federico II"
Naples, 80100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 3, 2020
First Posted
October 9, 2020
Study Start
October 1, 2019
Primary Completion
February 25, 2020
Study Completion
February 28, 2020
Last Updated
February 3, 2021
Record last verified: 2021-02