Adherence to lifestyle changes for age-related macular degeneration
- Pilot Study -

Age-related macular degeneration is a frequent eye disease in the elderly
affecting the center of retina, i.e., the macula. Despite current treatments
for the wet form of this disease, it is still the most frequent cause of
blindness in the Western world. The disease is the result of the interplay
between genetic and environmental factors such as smoking, unhealthy diet, and
lack of physical activity. The current clinical recommendations are aimed
towards these lifestyle factors: a healthy diet, no smoking, regular physical
exercise, and use of antioxidant supplementation. Although assumed to be low by
clinicians as they feel patients find it difficult to actually alter their
lifestyle, the adherence and feasibility to these recommendations in clinical
ophthalmology practice is unclear. Individualizing the patients* risk of
blindness and lifestyle changes, as well as coaching may positively influence
adherence strategies, which are part of effective *Behavioral Change
Techniques* (BCTs). This study compares the adherence to these strategies aimed
to prevent blindness from AMD through a healthier lifestyle.

Pre-pilotfase:
To optimize procedures and cost efficiency in the design of the pilot phase, we
address the following questions:

1. Which systemic factors are most useful to monitor AMD supplement intake?
2. Can these factors be measured by finger prick-derived dried blood spots?
3. Does the bioavailability and effect differ between important brands of
supplements?


Pilot study:

Primary objective(s):
Perform a pilot study to test feasibility and acceptability, i.e.: whether
personal risk profiling and/or coaching can help stimulate conversion and
adherence to a healthier lifestyle; patient and physician experience regarding
motivational strategies that support adherence to AMD-related clinical
lifestyle recommendations.

Secondary Objective(s):
Changes in macular pigment optical density (MPOD); changes in visual acuity;
and progression of AMD.

Pre-pilot phase:
Crossover open label intervention study

Pilot study
Open label randomized clinical trial.

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 recommended established AREDS 2 formula containing
vitamins, minerals and antioxidants: Vitamin C (L- ascorbic acid) 500mg,
vitamin E (DL- alpha-tocopheryl acetate) 400 mg, Zinc (zinc sulphate) 25 mg,
Copper (Copper gluconate) 2 mg, lutein from Tagetes erecta 10 mg
• Supplement B: Eyewise formula containing vitamins, minerals and antioxidants
from plant polyphenols as concentrated extracts: Lutein (pure, free form) 20
mg, Zeaxanthin 1000µg, Bilberry (50mg from a 4:1 extract) 200mg, Blackberry (50
mg from a 4:1 extract) 200 mg, Grape seed(10mg from a 50:1 extract) 500 mg,
Riboflavin (B2) 0,7 mg, Zinc 5 mg


Pilot study

Included participants: N = 210

• *Standard recommendations*: The first group (n=70) will receive standard care
recommendations (according to Netherlands Scientific Society of Ophthalmology
2014, *Richtlijn Leeftijdsgebonden Maculadegeneratie;): 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 recommendations plus personalized risk profiling. A risk scoring based
on currently available prediction tools will be used to determine personalized
risks of conversion to late AMD and the potential gain from lifestyle
improvement. Individuals will be informed about their own risk profile and a
personalized strategy will be communicated.

• Standard recommendations + Risk profiling + coaching*: The third group
(n=70) receives standard care (see 1); personalized risk profiling (see 2);
plus coaching. A coach will employ behavioral change techniques (BCT) to
enhance adherence using motivational interviews, feedback on behavior; and
focus on the advantages of following recommendations.

Pre-pilot phase

Participation in the study does not carry risks that exceed regular care. The
diet, anti-oxidant supplementation and lifestyle recommendations have been
accepted as clinical guidelines for AMD. The burden for participants is mainly
to undergo regular blood draws, to collect whole blood samples on paper (known
as dried blood spot (DBS)) MPOD measurements and to fill in an online food
questionnaire. Participants will not be paid for their participation.


Pilot study

This is a pilot study with standard clinical measurements in opthalmologic
practices. Participation in the study does not carry risks that exceed regular
patient care. Pupil dilation are a potential burden but is necessary to view
the posterior segment of the eye. Side effects of these drops include
photophobia and reduced accommodative power during 2 hours. The diet,
anti-oxidant and omega 3 supplementation and lifestyle recommendations have
been accepted as clinical guidelines for AMD. The burden for patients is mainly
to participate in the study with regular check-ups, to take dried blood spot
assessment (dbsa) in 20µL Mitra tip and/or collecting feces. Patients will not
be paid for their participation. Important benefits of participating in this
study include three free eye examinations, referral to an ophthalmologist if
necessary, and lifestyle advice to prevent or reduce AMD.