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 @ 4:07 PM
Ignite Modification Date:
2025-12-24 @ 4:07 PM
NCT ID:
NCT01375166
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged over 18 years, nonsmokers
* Normal findings in the medical history (except diabetes) and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* normal laboratory findings (except diabetes associated parameters) unless the investigator considers the abnormality to be clinically irrelevant
* normal ophthalmic findings (except mild diabetic retinopathy), Ametropia less than 6 diopters
* inclusion criterion of patients is type I diabetes with non or mild non-proliferative retinopathy
Exclusion criteria
Any of the following will exclude a healthy subject from the study:
* Regular use of vasoactive drugs
* Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks
* History or presence of any ocular pathology
* History or family history of epilepsy
* Systemic hypertension defined as systolic blood pressure \>150mmHg, diastolic blood pressure \>90mmHg
* Pregnancy
Any of the following will exclude a subject with diabetes from the study:
* Presence of non-insulin dependent diabetes, maturity onset diabetes of the young (MODY diabetes)
* History or presence of any other diabetes induced vascular pathologies or any other ocular condition other then diabetic retinopathy
* Best corrected visual acuity \<0.8
* Previous laser photocoagulation treatment
* Systemic hypertension defined as systolic blood pressure \>150mmHg, diastolic blood pressure \>90mmHg
* History or family history of epilepsy
* Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks
* Pregnancy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01375166
Study Brief:
Protocol Section:
NCT01375166