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The macular pigment (MP) in humans consists of the yellow, blue-absorbing carotenoids lutein and zeaxanthin. The highest concentrations of lutein and zeaxanthin are found in the fovea. Since light entering the eye passes through the MP before reaching the photo receptors it absorbs a significant portion of short-wavelength light. There is evidence that this absorbing properties of the MP as well as the ability of inactivating highly reactive oxygen species are protective for the retina.
Age-related macular degeneration is the leading cause of blindness among developed countries. The pathogenesis of this disease remains unknown. There is, however, evidence that low fruit and vegetable consumption increases the risk of Age-Related Macular Degeneration (AMD). Accordingly, it has been hypothesized that lutein supplementation may be beneficial in AMD. The present study investigates whether 6 months lutein supplementation increases MP optical density (OD), influences visual acuity, depth and dimension of central scotoma and alters symptoms in patients with AMD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Lutamax |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lutamax (leutein) | Dietary Supplement | leutein 20 mg for 3 months, then lutein 10 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Macular pigment optical density (MPOD) as measured with optical reflectometry | 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity using ETDRS charts | 15 minutes | |
| Central visual field defects assessed with scanning laser scotometry | 30 minutes | |
| Changes in fundus appearance as documented with fundus photos |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ursula Schmidt-Erfurth, Prof. Dr. | Department of Opthalmology, Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Pharmacology, Medical University of Vienna | Vienna | Austria |
| 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. | |
| 21873668 | Derived | Weigert G, Kaya S, Pemp B, Sacu S, Lasta M, Werkmeister RM, Dragostinoff N, Simader C, Garhofer G, Schmidt-Erfurth U, Schmetterer L. Effects of lutein supplementation on macular pigment optical density and visual acuity in patients with age-related macular degeneration. Invest Ophthalmol Vis Sci. 2011 Oct 17;52(11):8174-8. doi: 10.1167/iovs.11-7522. |
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| placebo |
| Dietary Supplement |
Placebo capsules identical in taste and appearance |
|
| 5 minutes |
| Determination of an increased systemic antioxidative state in plasma and low density lipoprotein and Plasma lutein concentrations | 5 minutes |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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