The effect of nutritional supplementation on retinal function

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17842302

Enrollment

120

Registered

2009-10-01

Start date

2009-01-01

Completion date

Unknown

Last updated

2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related macular disease Eye Diseases Other retinal disorders

Interventions

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 gro

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Multifocal electroretinogram amplitudes and latencies, assessed every 20 weeks for a period of 80 weeks	—

Secondary

Measure	Time frame
Macular pigment optical density, assessed every 20 weeks for a period of 80 weeks	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026