ThalassemiaNCT04582110
The Role of OCTA in Patients Affected by Beta Thalassemia
An observational study of Thalassemia, run by Federico II University at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Thalassemia
- What is being tested?
- Optical coherence tomography angiography
- How many people
- 82 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2019to 28 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The participans were older than 35 years with diagnosis of Beta Thalassemia. They did not present other ophthalmological diseases.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Thalassemia
- Being tested
- Optical coherence tomography angiography
- Medical subject headings
- Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomography angiographyDiagnostic test
Each subject underwent Optical coherence tomography angiography (a non-invasive, fast, diagnostic imaging technique)
| Study group | Role | What they receive |
|---|---|---|
| Patients with Beta Thalassemia | Patients with previous diagnosis of Beta Thalassemia Receives: Diagnostic Test: Optical coherence tomography angiography | |
| Control Group | Healthy fellow eyes without actual and previous ocular trauma Receives: Diagnostic Test: Optical coherence tomography angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Four months
Secondary outcomes (1)
The measurements of retinal structural parameters in patients with Beta Thalassemia, using optical coherence tomography.
The parameters analyzed by optical coherence tomography were: ganglion cell complex and retinal nerve fiber layer
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start1 Oct 2019
- Primary completion25 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThalassemiaStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilda Cennamo, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582110
- Sponsor's protocol ID
- 1002/19
- Status last verified
- Feb 2021
- First submitted
- 3 Oct 2020
- Last updated
- 3 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal and Choriocapillaris Vascular Features in Patients With Beta Thalassemia by Means of Optical Coherence Tomography Angiography
- ClinicalTrials.gov ID
- NCT04582110
- Acronym / sponsor ID
- 1002/19
- Conditions
- Thalassemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Beta Thalassemia | – | Diagnostic Test: Optical coherence tomography angiographyPatients with previous diagnosis of Beta Thalassemia |
| Control Group | – | Diagnostic Test: Optical coherence tomography angiographyHealthy fellow eyes without actual and previous ocular trauma |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The participans were older than 35 years with diagnosis of Beta Thalassemia. They did not present other ophthalmological diseases.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical coherence tomography angiographyEach subject underwent Optical coherence tomography angiography (a non-invasive, fast, diagnostic imaging technique) | Diagnostic test | Control Group, Patients with Beta Thalassemia |
Primary outcome
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
1 secondary outcome
The measurements of retinal structural parameters in patients with Beta Thalassemia, using optical coherence tomography.
Time frame: Four months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
Related trials for Thalassemia
Active, not recruiting
Evaluation the Safety and Efficacy of KL003 Cell Injection in the Treatment of Transfusion-dependent β-thalassemia.
Transfusion-dependent Beta-Thalassemia
RecruitingObservational study
Growth and Development-related Outcomes in Children With Transfusion-dependent Beta-thalassemia After Gene Therapy
Transfusion-dependent Beta-Thalassemia, Gene Therapy
Not yet recruiting
Gene Therapy of Beta Thalassemia Using a Self-inactivating Lentiviral Vector
Beta-Thalassemia
RecruitingPhase 1/2
β-Thalassemia Treatment With KL003 Cell Injection
Transfusion-dependent Beta-Thalassemia
Active, not recruitingPhase 3
A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)
Non-Transfusion-dependent Alpha-Thalassemia, Non-Transfusion-dependent Beta-Thalassemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thalassemia, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The measurements of retinal and choriocapillaris features in patients with Beta Thalassemia, using optical coherence tomography angiography. (time frame: Four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.