The effect of a lutein based nutritional supplement on non-exudative age-related macular degeneration (AMD): a double-masked randomised controlled trial

Not Applicable

Completed

• Conditions: Age-related macular degeneration; Eye Diseases; Macular degeneration

• Registration Number: ISRCTN78467674
• Lead Sponsor: Aston University (UK)

Brief Summary

2003 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/14594455 2008 results in https://www.ncbi.nlm.nih.gov/pubmed/18294739

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-09-11
• Study Completion: 2005-01-01
• Last Update Posted: 12 February 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 159

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.; 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 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 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Distance and near Visual Acuity (VA) measured using Bailey-Lovie logMAR charts<br>2. Contrast sensitivity (CS) measured using a Pelli-Robson chart <br>3. Colour vision measured using the PV-16 quantitative colour vision test <br>4. Macular Mapping (MM) test <br>5. Eger Macular Stressometer (EMS) used to assess glare recovery<br>6. Fundus photographs of the macular will be assessed using colour and edge analysis software<br><br>Data collection will take place at baseline, nine, and 18 months.;1. Distance and near Visual Acuity (VA) measured using Bailey-Lovie logMAR charts<br>2. Contrast sensitivity (CS) measured using a Pelli-Robson chart <br>3. Colour vision measured using the PV-16 quantitative colour vision test <br>4. Macular Mapping (MM) test <br>5. Eger Macular Stressometer (EMS) used to assess glare recovery<br>6. Fundus photographs of the macular will be assessed using colour and edge analysis software<br><br>Data collection will take place at baseline, nine, and 18 months.

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration;Not provided at time of registration