Central Retinal Enrichment Supplementation Trials - enrichment of macular pigment in subjects with age-related macular degeneration (AMD)

Completed

• Conditions: Age-related macular degeneration (AMD); Eye Diseases; Degeneration of macula and posterior pole

• Registration Number: ISRCTN13894787
• Lead Sponsor: European Research Council (ERC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-22
• Last Update Posted: 20 November 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

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

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 < 6/12
4. Spectacle prescription 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 < 6/12
4. Spectacle prescription of > ±5D
5. Recent history of carotenoid supplementation
6. Presence of other ocular pathology
7. Diabetes

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Contrast sensitivity at 24 months of supplementation. The level of significance for changes will be set at 0.05