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The primary objective of LUTEGA is it to determine the long term effect (about 1 year) of the supplementation with a fixed combination of lutein/zeaxanthin and omega-3- fatty acids on the optical density (OD) of macular pigment in patients with non- exudative age related maculopathy.
Furthermore, it is to be examined whether changes of the optical density are different dosages dependent. Possible changes of lipofuscin content and effect on drusen in AMD patients are studied. The measurement of optical density of macular pigment uses the 1- wavelength reflection method recording reflection images at 460 nm by a fundus camera. The patients are investigated at baseline and are followed up over one year in four more visits. In addition to the OD- measurement each examination includes standardized visual acuity test (ETDRS), amsler- grid, slit lamp biomicroscopy, fundus photography (color and autofluorescence) and a blood sample.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 20mg Lutein, 2mg Zeaxanthin, 510 mg Omega-3-FA; daily supplementation about one year |
|
| 2 | Active Comparator | 10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA; daily supplementation about one year |
|
| 3 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lutein/ Zeaxanthin + Omega-3-FA | Dietary Supplement | 20mg Lutein, 2mg Zeaxanthin, 510 mg Omega-3-FA; daily supplementation about one year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Optical density of macular pigment | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jürgen Strobel, MD | University Hospital, Jena | Study Director |
| Jens Dawczynski, MD | University Hospital, Jena | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, University Hospital | Jena | 07743 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37702300 | Derived | Evans JR, Lawrenson JG. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration. Cochrane Database Syst Rev. 2023 Sep 13;9(9):CD000254. doi: 10.1002/14651858.CD000254.pub5. | |
| 23695657 | Derived | Dawczynski J, Jentsch S, Schweitzer D, Hammer M, Lang GE, Strobel J. Long term effects of lutein, zeaxanthin and omega-3-LCPUFAs supplementation on optical density of macular pigment in AMD patients: the LUTEGA study. Graefes Arch Clin Exp Ophthalmol. 2013 Dec;251(12):2711-23. doi: 10.1007/s00417-013-2376-6. Epub 2013 May 22. |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014975 | Lutein |
| D065146 | Zeaxanthins |
| ID | Term |
|---|---|
| D024341 | Xanthophylls |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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| Lutein/ Zeaxanthin + Omega-3-FA | Dietary Supplement | 10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA; daily supplementation about one year |
|
| Placebo | Dietary Supplement | 0 mg Lutein, Zeaxanthin, Omega-3-FA |
|
| 23519529 | Derived | Arnold C, Winter L, Frohlich K, Jentsch S, Dawczynski J, Jahreis G, Bohm V. Macular xanthophylls and omega-3 long-chain polyunsaturated fatty acids in age-related macular degeneration: a randomized trial. JAMA Ophthalmol. 2013 May;131(5):564-72. doi: 10.1001/jamaophthalmol.2013.2851. |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |