Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2019-05-01
2020-04-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Beta-Thalassemia group
Patients suffering from beta thalassemia major or intermedia will be included in this group
EDI-OCT
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
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.
Interventions
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EDI-OCT
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
85 Years
ALL
Yes
Sponsors
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University Hospital of Patras
OTHER
Responsible Party
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Constantinos D. Georgakopoulos, MD, PhD
Associate Professor in Ophthalmology
Locations
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Department of Ophthalmology, General University Hospital of Patras
Pátrai, Achaea, Greece
Countries
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Other Identifiers
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9894 / 20 -5 -2016
Identifier Type: -
Identifier Source: org_study_id
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