Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT01123369
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT01123369
Study Brief:
Protocol Section:
NCT01123369