Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation on Optical Density of AMD Patients (LUTEGA) (LUTEGA)
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ClinicalTrials.gov Identifier: NCT00763659 |
Recruitment Status :
Completed
First Posted : October 1, 2008
Last Update Posted : July 20, 2012
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Age Related Maculopathy | Dietary Supplement: Lutein/ Zeaxanthin + Omega-3-FA Dietary Supplement: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 172 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation on Optical Density of AMD Patients (LUTEGA) |
Study Start Date : | May 2008 |
Actual Primary Completion Date : | September 2011 |
Actual Study Completion Date : | September 2011 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
20mg Lutein, 2mg Zeaxanthin, 510 mg Omega-3-FA; daily supplementation about one year
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Dietary Supplement: Lutein/ Zeaxanthin + Omega-3-FA
20mg Lutein, 2mg Zeaxanthin, 510 mg Omega-3-FA; daily supplementation about one year |
Active Comparator: 2
10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA; daily supplementation about one year
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Dietary Supplement: Lutein/ Zeaxanthin + Omega-3-FA
10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA; daily supplementation about one year |
Placebo Comparator: 3
Placebo
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Dietary Supplement: Placebo
0 mg Lutein, Zeaxanthin, Omega-3-FA |
- Optical density of macular pigment [ Time Frame: 12 months ]

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Ages Eligible for Study: | 50 Years to 95 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All non- exudative forms of age related maculopathy
Exclusion Criteria:
- Exudative age related maculopathy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763659
Germany | |
Department of Ophthalmology, University Hospital | |
Jena, Germany, 07743 |
Study Director: | Jürgen Strobel, MD | University Hospital, Jena | |
Principal Investigator: | Jens Dawczynski, MD | University Hospital, Jena |
Responsible Party: | Jens Dawczynski, Prof. Dr. med. jens Dawczynski, University of Leipzig |
ClinicalTrials.gov Identifier: | NCT00763659 |
Other Study ID Numbers: |
2032-06/07 |
First Posted: | October 1, 2008 Key Record Dates |
Last Update Posted: | July 20, 2012 |
Last Verified: | July 2012 |
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |