Age-related macular degeneration (AMD) Eye Diseases Degeneration of macula and posterior pole
Conditions
Interventions
Current interventions as of 21/01/2014:
Intervention 1: 10 mg lutein, 10 mg meso-zeaxanthin and 2 mg zeaxanthin plus 500 mg vitamin C, 400 IU of vitamin E, 25 mg zinc and 2 mg copper.
Intervention 2:
Sponsors
European Research Council (ERC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 21/01/2014: 1. Early stage AMD in at least one eye (between one and eight on the AREDS severity scale) 2. Corrected distance visual acuity of = 6/12 3. Spectacle prescription of = ±5D 4. Have not taken eye-related dietary supplements containing the macular carotenoids (lutein, zeaxanthin and/or meso-zeaxanthin) 5. No other ocular pathology 6. No diabetes Previous inclusion criteria: 1. Early stage non-visually consequential AMD in at least one eye (between one and eight on the Wisconsin severity scale) and no visually consequential (or late stage) AMD in the fellow eye 2. Corrected distance visual acuity of = 6/12 3. Spectacle prescription of = ±5D 4. Have not taken eye-related dietary supplements containing the macular carotenoids (lutein, zeaxanthin and/or meso-zeaxanthin) in the previous twelve months 5. No other ocular pathology 6. No diabetes
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 21/01/2014: 1. No early stage AMD in at least one eye (between one and eight on the AREDS severity scale) 2. Presence of late stage AMD in either eye 3. Corrected distance visual acuity of ±5D 5. Recent history of carotenoid supplementation 6. Presence of other ocular pathology 7. Diabetes Previous exclusion criteria: 1. No early stage non-visually consequential AMD in at least one eye (between one and eight on the Wisconsin severity scale) 2. Presence of visually consequential (or late stage) AMD in either eye 3. Corrected distance visual acuity of ±5D 5. Recent history of carotenoid supplementation 6. Presence of other ocular pathology 7. Diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Contrast sensitivity at 24 months of supplementation. The level of significance for changes will be set at 0.05 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 28/01/2014: 1. Contrast sensitivity (measured using the Functional Vision Analyzer and the LogMAR ETDRS test chart [Test Chart 2000 Pro]) 2. Glare disability (measured with the Functional Vision Analyzer) 3. Photostress recovery (measured by threshold contrast sensitivity before and after a 10-second exposure to blue photostress lamp) 4. Macular pigment (measured using customised heterochromatic flicker photometry [Macular Metrics II Maculux] and dual wavelength autofluorescence [Heidelberg Engineering Spectralis]) 5. Visual acuity (measured using the LogMAR ETDRS test chart [Test Chart 2000 Xpert]) 6. Light scatter (measured using the Oculus C-Quant) 7. Foveal architecture (measured using the Heidelberg Engineering Spectralis) 8. AMD morphology (based on retinal grading at the Reading Centre, Moorfields Eye Hospital) 9. Serum carotenoid concentrations (measured by high performance liquid chromatography analysis) 10. Cognitive function (measured using the Cambridge Cognition CANTAB [Cambridge Neuropsychological Test Automated Battery] software) 11. Reading acuity (measured using the Radner Reading Chart) 12. Reading speed (measured using the Radner Reading Chart) Measured at baseline, 6, 12, 18 and 24 months Previous secondary outcome measures: 1. Glare disability: measured by the Functional Vision Analyzer) 2. Photostress recovery (measured by threshold contrast sensitivity before and after a 10 second exposure to blue photostress lamp) 3. Macular pigment (measured using customised heterochromatic flicker photometry [Macular Metrics II Maculux] and dual wavelength autofluorescence [Heidelberg Engineering Spectralis]) 4. Visual acuity (measured using Snellen letters [Thomson chart]) 5. Light scatter (measured using the C-Quant) 6. Foveal architecture (measured using the Heidelberg Engineering Spectralis and the Zeiss Visucam 200) 7. Serum carotenoid concentrations (measured by high performance liquid chromatography analy | — |
Countries
Ireland, United Kingdom
Outcome results
None listed