- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04067258
Choroidal Thickness in Beta-thalassemia Patients
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.
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Achaea
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Patras, Achaea, Greece, GR26504
- Department of Ophthalmology, General University Hospital of Patras
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Inclusion Criteria:
- Beta thalassemia patients undergoing blood transfusions
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Beta-Thalassemia group
Patients suffering from beta thalassemia major or intermedia will be included in this group
|
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. |
Control group
Healthy age and sex matched volunteers will be included in this group
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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8-10 am
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Choroidal thickness nasally to the fovea
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 at anatomic locations nasally to the subfoveal point
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8-10 am
|
Choroidal thickness inferiorly to the fovea
Time Frame: 8-10 am
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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
|
8-10 am
|
Choroidal thickness temporally to the fovea
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 at anatomic locations temporally to the subfoveal point
|
8-10 am
|
Choroidal thickness superiorly to the fovea
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 at anatomic locations superiorly to the subfoveal point
|
8-10 am
|
Peripapillary choroidal thickness (inferior, superior, nasal and temporal fields)
Time Frame: 8-10 am
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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.
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8-10 am
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9894 / 20 -5 -2016
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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