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

NCT01123369 | Completed

• 2 other identifiers: SEI 10-001HR#18890
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Sickle Cell Disease

Keywords

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• Patient Care

  The use of Spectralis HRA+OCT gives us visualization of the individual layers of the retina to determine if there are underlying changes not seen clinically in the gross ophthalmic posterior segment exam. This knowledge will aid the care of African-Americans with sickle cell disease to enable greater understanding of the ocular disease progression leading to earlier eye screenings, possible novel treatments and ultimately visual loss prevention

  6 months

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Approximately 60 subjects of both sexes of African American race with or without sickle cell disease.

You may qualify if:

• SUBJECTS approximately 60 subjects of both sexes of African American race with or without sickle cell disease.
• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (2)

Medical University of South Carolina, Storm Eye Institute

Charleston, South Carolina, 29425, United States

Location

MUSC Storm Eye Institute

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

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

Study Officials

• Esther M Bowie, MD

  Medical University of South Carolina, Storm Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 25, 2010
• First Posted: May 14, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: September 14, 2010

Record last verified: 2010-09

Locations

US (2)