The effect of nutritional supplementation on retinal function

ISRCTN ISRCTN17842302
DOI https://doi.org/10.1186/ISRCTN17842302
Secondary identifying numbers N/A
Submission date
21/09/2009
Registration date
01/10/2009
Last edited
12/04/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Emma Berrow
Scientific

Aston University
Aston Triangle
Birmingham
B4 7ET
United Kingdom

Study information

Study designSingle-blind single-centre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe effect of nutritional supplementation on retinal function: a randomised controlled trial
Study objectivesNutritional supplementation may have an effect on retinal function. A randomised controlled trial comparing those taking a nutritional supplement with a control group.
Ethics approval(s)Aston University Ethics Committee, 01/10/2008, ref: REG/06/288[1]
Health condition(s) or problem(s) studiedAge-related macular disease
InterventionNutritional 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 typeSupplement
Primary outcome measureMultifocal electroretinogram amplitudes and latencies, assessed every 20 weeks for a period of 80 weeks
Secondary outcome measuresMacular pigment optical density, assessed every 20 weeks for a period of 80 weeks
Overall study start date01/01/2009
Completion date31/12/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit80 Years
SexBoth
Target number of participants120
Key inclusion criteriaAll 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
Key exclusion criteria1. 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
Date of first enrolment01/01/2009
Date of final enrolment31/12/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Aston University
Birmingham
B4 7ET
United Kingdom

Sponsor information

Bausch and Lomb (UK)
Industry

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

ROR logo "ROR" https://ror.org/0560gb543

Funders

Funder type

Industry

Bausch and Lomb (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

11/04/2017: No publications found in PubMed, verifying study status with principal investigator.