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OpenTrials
Completed

NCT Number: NCT00763659

Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation on Optical Density of AMD Patients (LUTEGA)

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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Key information

Age range

50 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology, University Hospital

Jena, 07743, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All non- exudative forms of age related maculopathy

Exclusion criteria

  • Exudative age related maculopathy

Treatment and study plan

Lutein/ Zeaxanthin + Omega-3-FA

Dietary Supplement

20mg Lutein, 2mg Zeaxanthin, 510 mg Omega-3-FA; daily supplementation about one year

Placebo

Dietary Supplement

0 mg Lutein, Zeaxanthin, Omega-3-FA

Primary outcomes

  1. Optical density of macular pigment

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Registry information

Acronym: LUTEGA

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 1, 2008
Registry last updated
Jul 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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