Risk Factors for Age Related Macular Degeneration
Conditions
Keywords
macular pigment optical density, age related macular degeneration, dry eye, vision
Brief summary
Low macular pigment optical density has been associated with increased risk of age-related macular degeneration, an important cause of vision problems in the elderly population. Dry eye is multifactorial disease of tears and the ocular surface associated with symptoms of dryness, grittiness, burning and redness of eyes. The risk of dry eye increases with age. The aim is to investigate the effects of sea buckthorn oil complemented with lutein on eye health, specifically on the macula.
Interventions
DIETARY_SUPPLEMENTSea buckthorn oil & lutein
Standardised sea buckthorn seed and pulp oil complemented with lutein
DIETARY_SUPPLEMENTPlacebo
Triglycerides of medium chain fatty acids
Sponsors
Aromtech Ltd.
Turku University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
\- macular pigment optical density equal to or less than 0,40 OD
Exclusion criteria
* diabetic retinopathy * macular changes associated with high blood pressure * signs of macular degeneration: classes 2, 3 and 4 according to the Rotterdam study (Mol Vis 2012: 657-74) * severe eye diseases, exluding cataract. The intervention will begina after surgery and recovery from cataract
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in macular pigment optical density from baseline to 6 mo | 0 mo, 3 mo, 6 mo | measurement of macular pigment optical density |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in symptoms of dry eye from baseline to 6 mo | 0 months, 3 months, 6 months | questionnaires, symptom logbook |
| Change in serum lipids (Triglycerides, HDL-cholesterol, LDL-cholesterol, total cholesterol) from baseline to 6 mo | 0 months, 6 months | analysis from serum samples |
| Change in serum markers of inflammation (hs-CRP) from baseline to 6 mo | 0 months, 6 months | analysis from serum samples |
| Change in circulating aminotransferases (ALAT, ASAT) from baseline to 6 mo | 0 months, 6 months | analysis from plasma samples |
| Change in vision aquity from baseline to 6 mo | 0 mo, 3 mo, 6 mo | ETDRS chart |
| Change in vision functioning from baseline to 6 mo | 0 mo, 3 mo, 6 mo | questionnaire |
| Change in tear film osmolarity from baseline to 6 mo | 0 mo, 3 mo, 6 mo | measurement of tear film osmolarity |
| Change in contrast sensitivity from baseline to 6 mo | 0 mo, 3 mo, 6 mo | analysis of contrast sensitivity |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in serum markers of sea buckthorn oil and lutein intake | 0 months, 6 months | analysis from serum samples |
Outcome results
None listed