Condition category
Eye Diseases
Date applied
20/06/2003
Date assigned
11/09/2003
Last edited
05/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.aston.ac.uk/downloads/lhs/website_protocol.pdf

Contact information

Type

Scientific

Primary contact

Miss Hannah Bartlett

ORCID ID

Contact details

Neuroscience Research Institute
School of Life and Health Sciences
Aston University
Aston Triangle
Birmingham
B4 7ET
United Kingdom
bartlehe@aston.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Age-related macular degeneration is the leading cause of blind registration in the developed world. One aetiological hypothesis involves oxidation and the intrinsic vulnerability of the retina to damage via this process. This has prompted interest in the role of antioxidants in the prevention and treatment of this eye disease.

Ethics approval

Approved by the Aston University Human Sciences Ethical Committee.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Age-related macular degeneration

Intervention

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

Intervention type

Supplement

Phase

Not Specified

Drug names

Lutein based nutritional supplement

Primary outcome measures

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 outcome measures

Not provided at time of registration

Overall trial start date

01/07/2003

Overall trial end date

01/01/2005

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

159

Participant 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.

Recruitment start date

01/07/2003

Recruitment end date

01/01/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Neuroscience Research Institute
Birmingham
B4 7ET
United Kingdom

Sponsor information

Organisation

Aston University (UK)

Sponsor details

Neurosciences Research Institute
School of Life and Health Sciences
Aston Triangle
Birmingham
B4 7ET
United Kingdom

Sponsor type

University/education

Website

http://www.aston.ac.uk/

Funders

Funder type

University/education

Funder name

College of Optometrists (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Protocol in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=14594455

Publication citations

  1. Protocol

    Bartlett H, Eperjesi F, A randomised controlled trial investigating the effect of nutritional supplementation on visual function in normal, and age-related macular disease affected eyes: design and methodology [ISRCTN78467674]., Nutr J, 2003, 2, 12, doi: 10.1186/1475-2891-2-12.

Additional files

Editorial Notes