Beta-ThalassemiaNCT04067258
Choroidal Thickness in Beta-thalassemia Patients
An observational study of Beta-Thalassemia, run by University Hospital of Patras at 1 site in Greece.
Trial summary
The purpose of this study is to examine choroidal thickness in beta-thalassemia patients and compare it to the one of healthy controls. An equal number of transfusion dependent beta-thalassemic patients and age and sex matched healthy volunteers will undergo spectral-domain optical coherence tomography utilizing the… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Beta-Thalassemia
- What is being tested?
- EDI-OCT
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 1 May 2019to 1 Apr 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with beta-thalassemia major or intermedia undergoing blood transfusions will be examined utilizing EDI-OCT. A group of equal healthy volunteers will also be included to serve as controls.
Who may be able to join
- Beta thalassemia patients undergoing blood transfusions
Who cannot join
- History of glaucoma, keratoconus, retinal disease, ocular trauma, ocular surgery, uveitis, amblyopia, strabismus, ocular vascular abnormalities
- Spherical refractive error greater than 4 diopters or cylindrical refractive error greater than 2 diopters
- History of other systemic disease such as uncontrolled hypertension, diabetes mellitus, or connective tissue disease.
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Ophthalmology, General University Hospital of Patras
Pátrai, Achaea, GR26504
About this study
Official title: Evaluation of Choroidal Thickness in Patients Suffering From Beta-thalassemia
The purpose of this study is to examine choroidal thickness in beta-thalassemia patients and compare it to the one of healthy controls.
An equal number of transfusion dependent beta-thalassemic patients and age and sex matched healthy volunteers will undergo spectral-domain optical coherence tomography utilizing the enhanced depth imaging application to visualize and measure the choroid.
Read the detailed description
Beta thalassemia is an inherited hemoglobinopathy, associated with defective production of beta-chain globin resulting in problematic HbA production. It is classified according to the severity as minor, intermedia and major. Patients suffering from beta-thalassemia intermedia and beta-thalassemia major require regular blood transfusions. Transfusion related hemosiderosis in these patients necessitates the use of chelating agents to prevent iron overload in vital organs such as the liver and heart.
A number of ocular abnormalities can present in beta-thalassemia patients. Those are categorized as pseudoxanthoma elasticum (PXE)-like changes that include angioid streaks, peau d'orange like fundus and optic nerve head drusen and non-PXE-like changes such as increased venous tortuosity.
Furthermore, it is well established that prolonged treatment with some of the chelating agents such as deferoxamine are associated with ocular toxicity, namely nyctalopia, colour perception anomalies, visual field disturbances, cataract formation, optic neuropathy and pigmentary retinopathy.
The pathophysiology of those ocular manifestations has not been fully clarified. The role of the choroid has not been determined since this particular tissue was previously unaccessible to imaging. Enhanced depth imaging optical coherence tomography is able to image the choroid providing reasonable clarity compared to spectral domain optical coherence tomography.
The aim of this study is to evaluate possible alterations of choroidal thickness in beta thalassemia as compared to healthy controls.
- Conditions
- Beta-Thalassemia
- Being tested
- EDI-OCT
- Keywords
- beta-thalassemia, choroidal thickness, enhanced depth imaging, optical coherence tomography
- Medical subject headings
- beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDI-OCTDiagnostic test
EDI-OCT (enhanced depth imaging spectral domain optical coherence tomography) wiil be performed in all study participants.
Three sets of measurements in the macular (horizontal and vertical) and peripapillary area will be averaged.
| Study group | Role | What they receive |
|---|---|---|
| Beta-Thalassemia group | Patients suffering from beta thalassemia major or intermedia will be included in this group Receives: Diagnostic Test: EDI-OCT | |
| Control group | Healthy age and sex matched volunteers will be included in this group Receives: Diagnostic Test: EDI-OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subfoveal choroidal thickness
Manual measurements of the choroid starting from the end of the retinal pigment epithelium throughout the outline of the sclera, will be conducted subfoveally
Measured: 8-10 am
Secondary outcomes (5)
Choroidal thickness nasally to the fovea
Manual measurements of the choroid starting from the end of the retinal pigment epithelium throughout the outline of the sclera, will be conducted at anatomic locations nasally to the subfoveal point
Measured: 8-10 am
Choroidal thickness inferiorly to the fovea
Manual measurements of the choroid starting from the end of the retinal pigment epithelium throughout the outline of the sclera, will be conducted at anatomic locations inferiorly to the subfoveal point
Measured: 8-10 am
Choroidal thickness temporally to the fovea
Manual measurements of the choroid starting from the end of the retinal pigment epithelium throughout the outline of the sclera, will be conducted at anatomic locations temporally to the subfoveal point
Measured: 8-10 am
Choroidal thickness superiorly to the fovea
Manual measurements of the choroid starting from the end of the retinal pigment epithelium throughout the outline of the sclera, will be conducted at anatomic locations superiorly to the subfoveal point
Measured: 8-10 am
Peripapillary choroidal thickness (inferior, superior, nasal and temporal fields)
Manual measurements of the choroid starting from the end of the retinal pigment epithelium throughout the outline of the sclera, will be conducted at the inferior, superior, nasal and temporal quadrants in the peripapillary area.
Measured: 8-10 am
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start1 May 2019
- Primary completion30 Mar 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Beta-ThalassemiaStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Constantinos D. Georgakopoulos, MD, PhD, University Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067258
- Sponsor's protocol ID
- 9894 / 20 -5 -2016
- Status last verified
- Jun 2020
- First submitted
- 21 Aug 2019
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Choroidal Thickness in Patients Suffering From Beta-thalassemia
- ClinicalTrials.gov ID
- NCT04067258
- Acronym / sponsor ID
- 9894 / 20 -5 -2016
- Conditions
- Beta-Thalassemia
- Keywords
- beta-thalassemia, choroidal thickness, enhanced depth imaging, optical coherence tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital of PatrasUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 26 Aug 2019 (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.
The purpose of this study is to examine choroidal thickness in beta-thalassemia patients and compare it to the one of healthy controls.
An equal number of transfusion dependent beta-thalassemic patients and age and sex matched healthy volunteers will undergo spectral-domain optical coherence tomography utilizing the enhanced depth imaging application to visualize and measure the choroid.
Detailed description
Beta thalassemia is an inherited hemoglobinopathy, associated with defective production of beta-chain globin resulting in problematic HbA production. It is classified according to the severity as minor, intermedia and major. Patients suffering from beta-thalassemia intermedia and beta-thalassemia major require regular blood transfusions. Transfusion related hemosiderosis in these patients necessitates the use of chelating agents to prevent iron overload in vital organs such as the liver and heart.
A number of ocular abnormalities can present in beta-thalassemia patients. Those are categorized as pseudoxanthoma elasticum (PXE)-like changes that include angioid streaks, peau d'orange like fundus and optic nerve head drusen and non-PXE-like changes such as increased venous tortuosity.
Furthermore, it is well established that prolonged treatment with some of the chelating agents such as deferoxamine are associated with ocular toxicity, namely nyctalopia, colour perception anomalies, visual field disturbances, cataract formation, optic neuropathy and pigmentary retinopathy.
The pathophysiology of those ocular manifestations has not been fully clarified. The role of the choroid has not been determined since this particular tissue was previously unaccessible to imaging. Enhanced depth imaging optical coherence tomography is able to image the choroid providing reasonable clarity compared to spectral domain optical coherence tomography.
The aim of this study is to evaluate possible alterations of choroidal thickness in beta thalassemia as compared to healthy controls.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta-Thalassemia group | – | Diagnostic Test: EDI-OCTPatients suffering from beta thalassemia major or intermedia will be included in this group |
| Control group | – | Diagnostic Test: EDI-OCTHealthy age and sex matched volunteers will be included in this group |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with beta-thalassemia major or intermedia undergoing blood transfusions will be examined utilizing EDI-OCT. A group of equal healthy volunteers will also be included to serve as controls.
Key inclusion criteria (1 listed)
- Beta thalassemia patients undergoing blood transfusions
Key exclusion criteria (3 listed)
- History of glaucoma, keratoconus, retinal disease, ocular trauma, ocular surgery, uveitis, amblyopia, strabismus, ocular vascular abnormalities
- Spherical refractive error greater than 4 diopters or cylindrical refractive error greater than 2 diopters
- History of other systemic disease such as uncontrolled hypertension, diabetes mellitus, or connective tissue disease.
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 |
|---|---|---|
| EDI-OCTEDI-OCT (enhanced depth imaging spectral domain optical coherence tomography) wiil be performed in all study participants. Three sets of measurements in the macular (horizontal and vertical) and peripapillary area will be averaged. | Diagnostic test | Beta-Thalassemia group, Control group |
Primary outcome
Subfoveal choroidal thickness
Time frame: 8-10 am
Manual measurements of the choroid starting from the end of the retinal pigment epithelium throughout the outline of the sclera, will be conducted subfoveally
5 secondary outcomes
Choroidal thickness nasally to the fovea
Time frame: 8-10 am
Choroidal thickness inferiorly to the fovea
Time frame: 8-10 am
Choroidal thickness temporally to the fovea
Time frame: 8-10 am
Choroidal thickness superiorly to the fovea
Time frame: 8-10 am
Peripapillary choroidal thickness (inferior, superior, nasal and temporal fields)
Time frame: 8-10 am
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 26 Jun 2020.
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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 Beta-Thalassemia, run by University Hospital of Patras at 1 site in Greece.
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 1 inclusion and 3 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 26 Jun 2020. 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 Greece. 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?
Subfoveal choroidal thickness (time frame: 8-10 am). 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 26 Jun 2020.