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 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT03997032
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Diabetes mellitus type 1 or 2
* No or mild non-proliferative diabetic retinopathy
* Normal findings in the medical history except diabetes unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings except mild non-proliferative retinopathy
* Ametropy ≤ 6 diopters
Exclusion Criteria:
* Participation in a clinical trial in the 3 weeks preceding the screening visit
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Presence or history of a severe medical condition relevant to the study, except diabetes, as judged by the clinical investigator
* Intake of dietary supplements containing folate within the three months before the screening visit
* Untreated or uncontrolled arterial hypertension (defined as either systolic blood pressure \>150 mmHg or diastolic blood pressure \>95 mmHg)
* Blood donation during the previous three weeks
* Moderate to severe non-proliferative or proliferative diabetic retinopathy
* Previous laser photocoagulation treatment
* History or family history of epilepsy
* Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
* Best corrected visual acuity \< 0.8 Snellen
* Ametropy \> 6 Dpt
* Pregnancy, planned pregnancy or lactating
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03997032
Study Brief:
Protocol Section:
NCT03997032