Carotenoid Supplementation and Normal Ocular Health
The Bioavailability of Retinal Carotenoids in the Older Human Eye and Their Effects on Photoreceptor Performance
1 other identifier
interventional
88
1 country
1
Brief Summary
Normal ageing affects vision as a result of preretinal and retinal changes. Photoreceptors, the light sensitive cells in the retina, degenerate and the rods (responsible for night vision) are most susceptible to damage with increasing age. Rod loss leads to poor vision in the dark which increases the risk of accidents amongst the elderly. Macular pigment (located in the photoreceptors)is thought to protect the retina and reduce the risk of age related changes. Dark adaptation, mediated by the rods, slows down with age, and is also reduced in AMD (age-related macular degeneration). Recent evidence suggests that lutein (the main component of macular pigment) supplementation improves the dark adaptation deficit in AMD subjects. Research into the effects of lutein in a normal human has not been previously conducted. Since the older population is increasing, our aim is to firstly establish the extent of night vision loss (using dark adaptometry) and secondly to examine the possibility of slowing down or reversing this loss through lutein supplementation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 16, 2014
CompletedFirst Posted
Study publicly available on registry
May 26, 2014
CompletedMay 26, 2014
April 1, 2014
2.4 years
April 16, 2014
May 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Changes in macular pigment optical density
12 months
Changes in serum lutein
12 months
Secondary Outcomes (1)
Changes in visual performance
12 months
Study Arms (2)
Active lutein group
ACTIVE COMPARATOR44 participants taking VisionAce daily for a period of 1 year
Placebo group
PLACEBO COMPARATOR44 participants taking placebo daily for a period of 1 year
Interventions
Eligibility Criteria
You may qualify if:
- Not on food supplements containing lutein or zeaxanthin
- Visual acuity at least 0.4 logMAR units (6/15 Snellen)
- \. Body mass index of less than 35 5. No diagnosed ocular disease (e.g. established AMD, cataract, glaucoma) 6. Age between 50 and 90
You may not qualify if:
- Diabetes
- Any diagnosed ocular disease (e.g. AMD, cataract, glaucoma)
- Under 50 and over 90 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Manchester
Manchester, M13 9PL, United Kingdom
Study Officials
- STUDY DIRECTOR
Ian Murray
University of Manchester
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Miss
Study Record Dates
First Submitted
April 16, 2014
First Posted
May 26, 2014
Study Start
November 1, 2011
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
May 26, 2014
Record last verified: 2014-04