Risk Factors for Age Related Macular Degeneration Clinical Trial
— SBEYE| Verified date | November 2014 |
| Source | Turku University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Finland: Ethics Committee |
| Study type | Interventional |
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.
| Status | Not yet recruiting |
| Enrollment | 90 |
| Est. completion date | August 2018 |
| Est. primary completion date | February 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 60 Years to 75 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Turku University Hospital | Aromtech Ltd. |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Change in serum markers of sea buckthorn oil and lutein intake | analysis from serum samples | 0 months, 6 months | No |
| Primary | Change in macular pigment optical density from baseline to 6 mo | measurement of macular pigment optical density | 0 mo, 3 mo, 6 mo | No |
| Secondary | Change in symptoms of dry eye from baseline to 6 mo | questionnaires, symptom logbook | 0 months, 3 months, 6 months | No |
| Secondary | Change in serum lipids (Triglycerides, HDL-cholesterol, LDL-cholesterol, total cholesterol) from baseline to 6 mo | analysis from serum samples | 0 months, 6 months | No |
| Secondary | Change in serum markers of inflammation (hs-CRP) from baseline to 6 mo | analysis from serum samples | 0 months, 6 months | No |
| Secondary | Change in circulating aminotransferases (ALAT, ASAT) from baseline to 6 mo | analysis from plasma samples | 0 months, 6 months | No |
| Secondary | Change in contrast sensitivity from baseline to 6 mo | analysis of contrast sensitivity | 0 mo, 3 mo, 6 mo | |
| Secondary | Change in vision aquity from baseline to 6 mo | ETDRS chart | 0 mo, 3 mo, 6 mo | |
| Secondary | Change in vision functioning from baseline to 6 mo | questionnaire | 0 mo, 3 mo, 6 mo | |
| Secondary | Change in tear film osmolarity from baseline to 6 mo | measurement of tear film osmolarity | 0 mo, 3 mo, 6 mo |