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
Scientific
Aston University
Aston Triangle
Birmingham
B4 7ET
United Kingdom
Study information
| Study design | Single-blind single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The effect of nutritional supplementation on retinal function: a randomised controlled trial |
| Study objectives | 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(s) | Aston University Ethics Committee, 01/10/2008, ref: REG/06/288[1] |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/2009 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Aston University
Birmingham
B4 7ET
United Kingdom
B4 7ET
United Kingdom
Sponsor information
Bausch and Lomb (UK)
Industry
Industry
106 London House
Kingston upon Thames
Surrey
KT2 6TN
United Kingdom
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
11/04/2017: No publications found in PubMed, verifying study status with principal investigator.
