To assess whether there is a change in visual function and status of the retina after a year of intervention in subjects with early signs of Age-related Macular Degeneration.
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the visual function by Best Corrected Visual Acuity.
Secondary outcome
To assess the visual function by Contrast Sensitivity.
To assess morphological changes of the retina by fundus photography.
To assess Visual performance and experience by questionnaire.
To assess Fundus Auto fluorescence.
To obtain information about both macular pigment density and distribution from
double wavelength Fundus Auto fluorescence is performed at Bonn University.
To measure Macular Pigment Optical Density (MPOD), Plasma lutein and zeaxanthin
levels, and to review a blood safety panel.
To assess dark adaptation at one centre (Manchester University)
To assess Cognitive function by psychometric testing in a subgroup (n=40) in
one centre (Tufts University, Boston, MA, USA).
Background summary
Visual and cognitive impairment affects nearly one in three to four
community-dwelling elders, and is associated with decreased quality of life as
well as increased disability and health care costs. Findings from previous
studies suggest that a carotenoid, lutein, which is related to a decreased risk
of AMD, may also be important in cognitive function in the elderly. Similarly,
DHA has been implicated in the prevention or delay in progression of
age-related visual and cognitive decline. This study proposes to evaluate
long-term intervention with a dairy based beverage containing eggs which are
enriched in a natural way for lutein, zeaxanthin and DHA. This food vehicle has
been chosen because of the high bioavailability of lutein contained in eggs.
Study objective
To assess whether there is a change in visual function and status of the retina
after a year of intervention in subjects with early signs of Age-related
Macular Degeneration.
Study design
The study is a double-blind, randomized, placebo-controlled trial designed to
test the effect of a dairy beverage containing lutein and DHA enriched eggs on
visual and cognitive function in subjects with early signs of AMD.
Intervention
Dietary supplement: A beverage with lutein, zeaxanthine, and DHA enriched egg.
Study burden and risks
Subjects will be seen four times, once for screening and 3 for subsequent study
visits. The methods used in this trial are commonly used techniques which have
been proven safe in either previous trials or clinical practice. Subjects*
sight will be limited for the investigated eye for a few hours after every
visit because of the use of tropicamide; this is standard practice at
ophthalmology departments with only sporadic and treatable side effects (acute
angle-closure glaucoma in 0.03%). Subjects in the intervention group are
expected to show a slower progression of the disease than those in the placebo
group.
Rotven 8
Oirlo 5808 AL
NL
Rotven 8
Oirlo 5808 AL
NL
Listed location countries
Age
Inclusion criteria
Early AMD (AREDS category 2)
o many small drusen, or
o a few intermediate-sized (63-124 micrometres in diameter) drusen, or
macular pigmentary changes
OR
- Intermediate AMD (AREDS category 3)
o extensive intermediate sized (63-124 micrometres in diameter) drusen, or
o at least one large (>125 micrometres in diameter) drusen or
o geographic atrophy not involving the foveal centre
- men and women age >50 years
- BMI 18-35 kg/m2
- Vision > 20/40 for Snellen visual acuity
Exclusion criteria
- ocular media opacity (severe cataract)
- history of active small bowel disease or resection
- atrophic gastritis
- history of hyperlipidemia or screening values as follows (LDL > 5.33mmol/L or 205mg/dL;
triglycerides > 4.52mmol/L or 400 mg/dL)
- hypertension (>150/90 mm Hg)
- diabetes mellitus (if also accompanied by signs of diabetic retinopathy)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01694680 |
| CCMO | NL48013.091.14 |