N/A
Completed N=168
Effects of Lutein and Zeaxanthin Supplementation on Early Age-related Macular Degeneration
Source: ClinicalTrials.gov NCT01528605 ↗Enrolled (actual)
168
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcomePrimary: Changes of Macular Pigment Optical Density (MPOD) During 48 Weeks and 2 Years — 0.315; 0.307; 0.315; 0.320 density units — p=<0.05
Summary
This study is to investigate the protective effects of supplemental lutein and zeaxanthin on early age-related macular degeneration (AMD) patients in China.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes of Macular Pigment Optical Density (MPOD) During 48 Weeks and 2 Years |
0.315; 0.307; 0.315; 0.320; 0.327; 0.300 | <0.05 sig |
| SECONDARY Changes of Serum Xanthophylls Concentrations During the Intervention |
0.330; 0.318; 0.301; 0.244; 0.258; 0.870 | <0.05 sig |
| SECONDARY Changes of Best-spectacle Corrected Visual Acuity (BSCVA) During the Intervention |
53.037; 54.769; 54.539; 56.840; 56.481; 55.038 | >0.05 |
| SECONDARY Changes of Contrast Sensitivity (CSF) Measured by CSV-100 During the Intervention |
— | — |
| SECONDARY Changes of Flash Recovery Time (FRT) Measured by MDD-2 Macular Adaptometer |
— | — |
| SECONDARY Changes From Baseline in Multifocal Electroretinogram (mfERG) at 48 Weeks |
— | — |
| SECONDARY Changes From Baseline in Microperimetry (MP) During the Intervention |
— | — |
| SECONDARY Changes of Food Pattern From Baseline by Food Frequency Questionnaire During the Intervention |
— | — |
Eligibility Criteria
Inclusion Criteria
- aged over 50 years, Chinese of the Han nationality
- diagnosed as age-related macular degeneration
- did not take lutein or zeaxanthin supplements in the past half a year
- good general health
- corrected visual acuity above 0.25 (20/80)
- did not take optical laser or medical treatments
Exclusion Criteria
- had other ocular diseases, such as glaucoma, macular pucker, optic neuropathy, diabetic retinopathy etc.
- had nervous system diseases, stroke, Type I diabetes
- had diseases effected nutrients absorption, such as Crohn' s disease
- had turbid ocular media or transplanted intraocular lenses
- reported abnormal digestive condition
Data sourced from ClinicalTrials.gov (NCT01528605). 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.