Age-related macular degeneration retinal aging/degeneration
Conditions
Interventions
Pre-pilot phase:
Included participants: N = 10
Each participant will take supplement A or B for 4 weeks, and, after a wash out
of 4 weeks, supplement B or A for 4 weeks.
• Supplement A: The recomme
): refrain from smoking
perform physical exercise regularly
increase the intake of dietary food groups
such as green leafy vegetables and fatty fish
and recommendations for
supplementation with antioxidants according an established formula and omega 3.
• *Standard recommendations + Risk profiling*: The second group (n=70) receives
standard rec
Sponsors
Oogheelkunde
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Pre-pilot phase Inclusion criteria: 1. Eligible to take two AMD supplements for 4 weeks each, Piot study: 1. Age: 55 years and older 2. Diagnosis: Early/intermediate AMD (based on fundus photographs; Rotterdam criteria: stage 2&3; AREDS criteria: category 2 and 3A), or unilateral late AMD
Exclusion criteria
Exclusion criteria: Pre-pilot phase: Subject who have a history of AMD or other systemic disease will be excluded from participation in this study, Pilot study: 1. Participation in other intervention studies for AMD 2. Living in retirement homes (difficulty in implementation of diet) 3. Diagnosis of dementia (because of unreliable dietary recall) 4. Persons with macular pathology other than AMD hindering appropriate grading of the macula 5. Persons diagnosed with late stage AMD in both eyes 6. Persons who are illiterate and have no independent trusted person with them to explain the informed consent form. 7. Persons diagnosed with liver and kidney insufficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pre-pilot phase Changes in biomarkers related to supplement intake, such as macular pigment optical density (MPOD); complement factors; inflammation markers (hsCRP and lipids); oxidative stress parameters (MDA, Nitro-tyrosine, 8-iso-PGF-2a by LC-MS/MS); and changes in AMD nutrients parameters (vitamin E, zinc, copper, lutein, zeaxanthin). Expected outcome: increase in AMD nutrient levels, decrease of complement levels and oxidative stress. The most promising biomarkers will be incorporated in the pilot study. Pilot study The primary outcome would be feasibility and acceptability of the interventions. More specifically: 1) The number (percentage) of participants in the different phases of dietary behaviour change (pre-contemplation, contemplation, preparation, action, relapse or maintenance) regarding following dietary recommendations. 2) The feasibility of the interventions in increasing the average serum levels of carotenoids, zinc, DHA, EPA, vitamin D and antioxidant capacity markers. 3) The acceptability of participants and health care providers regarding dietary counselling (qualitative data). | — |
Secondary
| Measure | Time frame |
|---|---|
| Pre-pilot phase Finger-prick blood measurements compared to conventional plasma/serum measurements Differences in outcome of the intake of AREDS2 compared to EYE-WISE Pilot study: 1. Changes in macular pigment optical density (MPOD) - complement activation; 2. Changes in visual acuity; 3. Progression of AMD. | — |
Countries
Netherlands
Outcome results
None listed