N/A
Completed N=60
The Zeaxanthin and Visual Function Study
Age-Related Macular Degeneration · Cognition Disorders
Source: ClinicalTrials.gov NCT00564902 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcomePrimary: Macular Pigment Optical Density — 0.48; 0.38; 0.42 Density units of Macular Pigment (du)
Summary
To evaluate if supplementation of zeaxanthin (with or without Lutein) is beneficial to patients with early and moderate Atrophic Age Related Macular Degeneration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 | — |
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.
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. Informational only — not medical advice.