Spectralis HRA+OCT Imaging of the Retina With Autofluorescence in Sickle Cell Disease

Completed

Conditions studied: Sickle Cell Disease

In brief

To determine the retinal and choroidal thickness in patients with sickle cell disease compared to age, race matched population without sickle cell disease to allow a better understanding of the clinical manifestations of sickle cell retinopathy. The purpose of this research study is to evaluate the relationship between sickle cell disease and the eye. The research study is recruiting African American population with or without Sickle Cell Disease. The investigator in charge of this study is Dr E. Bowie. Approximately 60 subjects of both sexes will be enrolled at the Medical University of South Carolina.

Key facts

Study ID

NCT01123369

Run by

Medical University of South Carolina

People needed

8

Starts

2010-02-01

Expected to finish

2010-07-01

Last updated by the study team

2010-09-14

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• SUBJECTS approximately 60 subjects of both sexes of African American race with or without sickle cell disease.
• Patient Inclusion Criteria:
• Subjects MUST fulfill the following conditions to qualify for enrollment into the trial
• Twelve years of age or older.
• Patients diagnosed with sickle cell disease (n=40) and an age, race matched control group of subjects (n=20) without sickle cell disease. Sickle disease is defined as a genetic blood disease due to the presence of an abnormal form of hemoglobin, namely hemoglobin S. It includes four genotypes: sickle cell trait (AS), sickle cell anemia (SS), sickle cell disease (SC) and sickle cell thalassemia (SThal). Patients with any of these genotypes will be included.
• Willing and able to comply with scheduled visit and other study procedure

You may not qualify if…

• Subject must not have a history of prior intraocular retinal surgery, prior laser photocoagulation, cryotherapy, active ophthalmic disease or abnormality (e.g. blepharitis, corneal infection), clinical evidence of trauma (including scarring).
• Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
• Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.
• Pregnant and nursing mothers.

Where it is running

• Medical University of South Carolina, Storm Eye Institute — Charleston, South Carolina, United States
• MUSC Storm Eye Institute — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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