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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT02090751
Eligibility Criteria:
Inclusion Criteria:
* They understand their rights as a research Participant and are willing and able to sign a Statement of Informed Consent.
* They are over 50 years and less than 80 years of age.
* They are willing and able to perform the experimental task required.
* They are not a current participant in other studies. Lifestyle factors
* Diet that includes animal and/or vegetable fats. Health factors
* Good ocular health, the following will be admitted Pseudophakia, aphakic with good VA (better than 6/12), AMD with AREDS category 1,2,or 3.
* Good systemic health, the following may be admitted Hypertension Thyroid disease Arthritis Depression
* Medication, that is not hepatotoxic or retinotoxic directly or by treating a disease that is may be admitted. Use British National Formulary (BNF) to check if unsure.
Exclusion Criteria:
* Unlikely to be available, willing, and able to attend
* Unable to give consent.
* Current participant in other studies.
* Subject to any condition that may adversely affect fat intake (proxy for Vit A) or retinal function.
Lifestyle factors
* Diet that excludes animal and/or vegetable fats.
Health factors
* Ocular Any active disease, e.g. · Glaucoma, Cataract if VA worse than 6/12 · Diabetic Retinopathy · Retinal detachment · Uveitis Treatments · Laser Sx. to cornea, capsule or retina · Recent cataract extraction within 12 weeks · Drops
* Systemic Diabetes Liver disease, Hepatitis: Past or present Digestive disorders, e.g. Crohns, irritable bowel syndrome (IBS), lactose intolerance Bowel surgery, stomach staple, ileostomy, colostomy Kidney disorder (elevated iron) Chronic alcoholism or drug abuse
* Medication, hepatotoxic or retinotoxic directly or by treating a disease that is. If unsure use BNF and seek advice of ophthalmologist/study leader. Examples include:
* Interferon alpha
* Vitamin A derivatives (Chronic eczema)
* Amiodarone (Heart disease)
* Chloroquine/Hydrochloroquine (Plaquenil) (Rheumatoid Arthritis/ Malaria)
* Tamoxifen (Breast Cancer)
* Chlorpromazine (Schizophrenia)
* Deferoxamine (Thalassemia, blood transfusions/ kidney disease)
* Phenothiazines (Anti-psychotic/epilepsy)
* Ethambutol (TB)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT02090751
Study Brief:
Protocol Section:
NCT02090751