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 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
NCT ID:
NCT00005761
Eligibility Criteria:
* VOLUNTEER INCLUSION CRITERIA:
Volunteers will be able to enroll if they:
* Have the ability to understand and sign an informed consent.
* Are able and willing to give a blood sample.
* Are healthy as determined by study Investigator.
* Have no chronic diseases.
* Do not exhibit any clinical indications of diabetes.
PARTICIPANT INCLUSION CRITERIA:
Participants will be able to enroll if they:
* Have the ability to understand and sign an informed consent.
* Are able and willing to give a blood sample.
* Have a clinical diagnosis of diabetes based on any one of the following criteria:
1. Documented history of plasma glucose value greater than or equal to 210 mg/dl on three different occasions.
2. Fasting blood sugar greater than or equal to 150 mg/dl on three different occasions.
3. Documented history of ketoacidosis.
4. Insulin dependency.
5. Documented history of abnormal glucose tolerance test.
EXCLUSION CRITERIA:
Neither volunteers nor participants will be eligible if they:
* Are under the age of 10.
* Have severe systemic disease(s) that compromise our ability to obtain an adequate examination.
* Have any of the following ocular characteristics or conditions in both eyes:
1. Opacities of the ocular media, limitations or pupillary dilation or any other problems sufficient to preclude good, quality stereo fundus photographs.
2. Ocular disease which confounds assessment of diabetic retinopathy such as advanced age-related macular degeneration, central serous choroidopathy, optic atrophy, retinal vein occlusion, active uveitis, significant explained or unexplained visual field loss, or any other type of retinopathy or retinal degeneration.
3. Chronic requirement for any ocular medication for other diseases, such as glaucoma.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Study:
NCT00005761
Study Brief:
Protocol Section:
NCT00005761