Age-related macular degeneration Eye Diseases Macular degeneration
Conditions
Interventions
The study formulation contains:
Lutein 10 mg
Vitamin C 250 mg
Vitamin E 34 mg
Vitamin A 750 µg
Zinc 10 mg
Copper 0.5 mg
Sponsors
Aston University (UK)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Have to provide written informed consent 2. Have to be available for three visits to Aston University 3. Have to present with no ocular pathology in one eye, or no ocular pathology other than dry AMD in one eye. A cataract grading system consisting of grades one, two and three for each of cortical, nuclear, and posterior subcapsular cataracts has been developed. Participants presenting with lens opacities precluding fundus photography are excluded. Throughout the trial period, progression of any type of cataract to the successive grade will require the participant to withdraw.;Inclusion criteria: 1. Have to provide written informed consent 2. Have to be available for three visits to Aston University 3. Have to present with no ocular pathology in one eye, or no ocular pathology other than dry AMD in one eye. A cataract grading system consisting of grades one, two and three for each of cortical, nuclear, and posterior subcapsular cataracts has been developed. Participants presenting with lens opacities precluding fundus photography are excluded. Throughout the trial period, progression of any type of cataract to the successive grade will require the participant to withdraw.
Exclusion criteria
Exclusion criteria: Exclusion criteria include type I and II diabetes because vitamin E has been shown to affect glucose tolerance and diabetic retinopathy may confound the results. Those taking Warfarin medication are excluded as zinc may decrease its absorption and activity, as are those who use nutritional supplements that potentially raise vitamin and mineral intake above safe limits. The most recent guidelines for upper limits of nutritional supplementation are set out in the UK Food Standards Agency report. Neovascular AMD and other ocular disease that could potentially interfere with the results are excluded.;Exclusion criteria: Exclusion criteria include type I and II diabetes because vitamin E has been shown to affect glucose tolerance and diabetic retinopathy may confound the results. Those taking Warfarin medication are excluded as zinc may decrease its absorption and activity, as are those who use nutritional supplements that potentially raise vitamin and mineral intake above safe limits. The most recent guidelines for upper limits of nutritional supplementation are set out in the UK Food Standards Agency report. Neovascular AMD and other ocular disease that could potentially interfere with the results are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Distance and near Visual Acuity (VA) measured using Bailey-Lovie logMAR charts 2. Contrast sensitivity (CS) measured using a Pelli-Robson chart 3. Colour vision measured using the PV-16 quantitative colour vision test 4. Macular Mapping (MM) test 5. Eger Macular Stressometer (EMS) used to assess glare recovery 6. Fundus photographs of the macular will be assessed using colour and edge analysis software Data collection will take place at baseline, nine, and 18 months.;1. Distance and near Visual Acuity (VA) measured using Bailey-Lovie logMAR charts 2. Contrast sensitivity (CS) measured using a Pelli-Robson chart 3. Colour vision measured using the PV-16 quantitative colour vision test 4. Macular Mapping (MM) test 5. Eger Macular Stressometer (EMS) used to assess glare recovery 6. Fundus photographs of the macular will be assessed using colour and edge analysis software Data collection will take place at baseline, nine, and 18 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration;Not provided at time of registration | — |
Countries
United Kingdom
Contacts
Public Contact; ;
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Outcome results
None listed