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

University of Jena

Status: Completed

Conditions: Age Related Maculopathy

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Lutein/ Zeaxanthin + Omega-3-FA

Study type: Interventional

Funder types: Other

Identifiers

NCT00763659

2032-06/07

Details and patient eligibility

About

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.

Enrollment: 172 patients

Sex: All

Ages: 50 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All non- exudative forms of age related maculopathy

Exclusion criteria

• Exudative age related maculopathy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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172 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Lutein/ Zeaxanthin + Omega-3-FA

Dietary Supplement: Lutein/ Zeaxanthin + Omega-3-FA

2

Active Comparator group

Description:

10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA; daily supplementation about one year

Treatment:

Dietary Supplement: Lutein/ Zeaxanthin + Omega-3-FA

Dietary Supplement: Lutein/ Zeaxanthin + Omega-3-FA

3

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo