N/A N=60 Randomized Double-blind Supportive Care

The Zeaxanthin and Visual Function Study

Age Related Macular Degeneration · Cognition Disorders

Bottom Line

View on ClinicalTrials.gov: NCT00564902 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2012

Primary outcome: Primary: Macular Pigment Optical Density — 0.48; 0.38; 0.42 Density units of Macular Pigment (du)

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 3R 3'R Zeaxanthin (Drug); Lutein (Dietary_supplement); Lutein and Zeaxanthin (Dietary_supplement)
Age: Adult, Older Adult · 45+ yrs
Sex: All
Sponsor: Chrysantis, Inc.
Primary completion: May 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Macular Pigment Optical Density	0.54; 0.52; 0.48	—
PRIMARY Macular Pigment Optical Density	0.54; 0.52; 0.48	—
PRIMARY Macular Pigment Optical Density	0.54; 0.52; 0.48	—
SECONDARY SHAPE Discrimination	0.5; 0.6; 0.6	—
SECONDARY Early Treatment Diabetic Retinopathy Study Distance Visual Acuity	98.9; 92.8; 96.8	—
SECONDARY Glare Recovery	25.2; 14.85; 16.65	—
SECONDARY Contrast Sensitivity Function Photopic Distance	310.5; 247.1; 254.7	—
SECONDARY 6.5 Degrees Tritan Threshold	4.46; 8.37; 3.45	—
SECONDARY 100% Kinetic Field	2704; 2207; 1129	—

Summary

To evaluate if supplementation of zeaxanthin (with or without Lutein) is beneficial to patients with early and moderate Atrophic Age Related Macular Degeneration.

Eligibility Criteria

Inclusion Criteria

diagnosis of atrophic AMD (ICD9 362.51) by stereo bio-ophthalmoscopy and at least one vision degrading visual-psychophysical abnormality associated with AMD in one or both eyes.
clear non-lenticular ocular media (cornea, aqueous and vitreous)
free of advanced glaucoma and diabetes or any other ocular or systemic disease that could affect central or parafoveal macula visual function

Exclusion Criteria

high risk retinal characteristics for advanced AMD or advanced AMD for which existing medical / surgical options are available
presence of ophthalmologically significant active exudative, AMD pathology by fluorescein angiography but also a single large drusen, >15, multiple intermediate drusen, parafoveal geographic atrophy or loss of vision in one eye due to advanced AMD
recent (within 6 months) cataract or retinal surgery
taking photosensitizing drugs such as phenothiazines and chloroquine
having taken lutein or zeaxanthin supplements within the past six months.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00564902). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.