Condition category
Eye Diseases
Date applied
21/09/2009
Date assigned
01/10/2009
Last edited
30/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Emma Berrow

ORCID ID

Contact details

Aston University
Aston Triangle
Birmingham
B4 7ET
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of nutritional supplementation on retinal function: a randomised controlled trial

Acronym

Study hypothesis

Nutritional supplementation may have an effect on retinal function. A randomised controlled trial comparing those taking a nutritional supplement with a control group.

Ethics approval

Aston University Ethics Committee, 01/10/2008, ref: REG/06/288[1]

Study design

Single-blind single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Age-related macular disease

Intervention

Nutritional supplement (oral) containing vitamin C 150 mg, vitamin E 15 mg, lutein 12 mg, zeaxanthin 0.6 mg, copper 400 µg, zinc 20 mg, omega-3 fatty acids 1,080 mg per day for 80 weeks.

Control group: no interventions (no placebo used)

Intervention type

Supplement

Phase

Not Applicable

Drug names

Vitamin C, vitamin E, lutein, zeaxanthin, copper, zinc, omega-3 fatty acids

Primary outcome measures

Multifocal electroretinogram amplitudes and latencies, assessed every 20 weeks for a period of 80 weeks

Secondary outcome measures

Macular pigment optical density, assessed every 20 weeks for a period of 80 weeks

Overall trial start date

01/01/2009

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

All participants (both males and females) must be aged 18 - 80 years.

1. For early age-related maculopathy (ARM) group in either eye or both eyes:
1.1. Drusen
1.2. Drusen with hyperpigmentation
1.3. Drusen with hypopigmentation
2. For early age-related maculopathy (ARM) group and normal group in either eye or both eyes:
2.1. Best corrected visual acuity of 6/9 or better
2.2. Good central fixation (necessary for the multifocal electroretinogram [mfERG])
2.3. Clear optical media
2.4. No signs of other retinal or optic nerve disease
2.5. Good general health
2.6. No medication that affects the retina

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Moderate to dense lens opacities
2. Intraocular lens
3. Corneal opacities
4. Glaucoma or ocular hypertension
5. Previous history of intraocular inflammation (e.g. uveitis)
6. Previous history of retinal detachment
7. Retinal disease
8. Previous retinal laser
9. Diabetes
10. Systemic hypertension
11. History of ocular trauma
12. Neurological disease
13. Advanced age-related macular disease (choroidal neovascularisation [CNV] or geographic atrophy [GA]) in the studied eye
14. Drugs causing retinal toxicity (chloroquine, cisplatin, oxazepam, vigabatrin)
15. Previous ocular surgery (excluding laser-assisted in situ keratomileusis [LASIK]/endothelial keratoplasty [EK])
16. Epilepsy

Recruitment start date

01/01/2009

Recruitment end date

31/12/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Aston University
Birmingham
B4 7ET
United Kingdom

Sponsor information

Organisation

Bausch and Lomb (UK)

Sponsor details

106 London House
Kingston upon Thames
Surrey
KT2 6TN
United Kingdom

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Bausch and Lomb (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

Publication citations

Additional files

Editorial Notes