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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00763659
Acronym
LUTEGA
Enrollment
172
Registered
2008-10-01
Start date
2008-05-31
Completion date
2011-09-30
Last updated
2012-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age Related Maculopathy

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTLutein/ Zeaxanthin + Omega-3-FA

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

DIETARY_SUPPLEMENTPlacebo

0 mg Lutein, Zeaxanthin, Omega-3-FA

Sponsors

University of Jena
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
50 Years to 95 Years
Healthy volunteers
No

Inclusion criteria

* All non- exudative forms of age related maculopathy

Exclusion criteria

* Exudative age related maculopathy

Design outcomes

Primary

MeasureTime frame
Optical density of macular pigment12 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026