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Choroidal Thickness in Beta-thalassemia Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04067258
Recruitment Status : Completed
First Posted : August 26, 2019
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
Constantinos D. Georgakopoulos, MD, PhD, University Hospital of Patras

Study Description
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Brief 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 enhanced depth imaging application to visualize and measure the choroid.


Condition or disease Intervention/treatment
Beta-Thalassemia Diagnostic Test: EDI-OCT

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
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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluation of Choroidal Thickness in Patients Suffering From Beta-thalassemia
Actual Study Start Date : May 1, 2019
Actual Primary Completion Date : March 30, 2020
Actual Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thalassemia

Groups and Cohorts
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Group/Cohort Intervention/treatment
Beta-Thalassemia group
Patients suffering from beta thalassemia major or intermedia will be included in this group
 Diagnostic Test: 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
 Diagnostic Test: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Choroidal thickness inferiorly 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 inferiorly to the subfoveal point

  3. 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

  4. 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

  5. Peripapillary choroidal thickness (inferior, superior, nasal and temporal fields) [ 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 the inferior, superior, nasal and temporal quadrants in the peripapillary area.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.

Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067258


Locations
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Greece
Department of Ophthalmology, General University Hospital of Patras
Patras, Achaea, Greece, GR26504
Sponsors and Collaborators
University Hospital of Patras
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Constantinos D. Georgakopoulos, MD, PhD, Associate Professor in Ophthalmology, University Hospital of Patras
ClinicalTrials.gov Identifier: NCT04067258    
Other Study ID Numbers: 9894 / 20 -5 -2016
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Constantinos D. Georgakopoulos, MD, PhD, University Hospital of Patras:
beta-thalassemia
choroidal thickness
enhanced depth imaging
optical coherence tomography
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn