Choroidal Thickness in Beta-thalassemia Patients

NCT04067258 | Completed

• 1 other identifier: 9894 / 20 -5 -2016
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Beta-Thalassemia

Keywords

beta-thalassemia; choroidal thickness; enhanced depth imaging; optical coherence tomography

Outcome Measures

Primary Outcomes (1)

• 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

  8-10 am

Secondary Outcomes (5)

• Choroidal thickness nasally to the fovea

  8-10 am

• Choroidal thickness inferiorly to the fovea

  8-10 am

• Choroidal thickness temporally to the fovea

  8-10 am

• Choroidal thickness superiorly to the fovea

  8-10 am

• Peripapillary choroidal thickness (inferior, superior, nasal and temporal fields)

  8-10 am

Study Arms (2)

Beta-Thalassemia group

Patients suffering from beta thalassemia major or intermedia will be included in this group

Diagnostic Test: EDI-OCT

Control group

Healthy age and sex matched volunteers will be included in this group

Diagnostic Test: EDI-OCT

Interventions

EDI-OCT DIAGNOSTIC_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.

Beta-Thalassemia group; Control group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Beta thalassemia patients undergoing blood transfusions

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital of Patras: lead

Study Sites (1)

Department of Ophthalmology, General University Hospital of Patras

Pátrai, Achaea, GR26504, Greece

Location

MeSH Terms

Conditions

beta-Thalassemia

Condition Hierarchy (Ancestors)

Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Ophthalmology

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 26, 2019
• Study Start: May 1, 2019
• Primary Completion: March 30, 2020
• Study Completion: April 1, 2020
• Last Updated: June 26, 2020

Record last verified: 2020-06

Locations

GR (1)