OBJECTIVE:

To determine whether vitamin E supplementation influences the incidence or rate of progression of age related maculopathy (AMD).

DESIGN:

Prospective randomised placebo controlled clinical trial.

SETTING:

An urban study centre in a residential area supervised by university research staff.

PARTICIPANTS:

1193 healthy volunteers aged between 55 and 80 years; 73% completed the trial on full protocol.

INTERVENTIONS:

Vitamin E 500 IU or placebo daily for four years.

MAIN OUTCOME MEASURES:

Primary outcome: development of early age related macular degeneration in retinal photographs. Other measures included alternative definitions of age related macular degeneration, progression, changes in component features, visual acuity, and visual function

RESULTS:

The incidence of early age related macular degeneration (early AMD 3) was 8.6% in those receiving vitamin E versus 8.1% in those on placebo (relative risk 1.05, 95% confidence interval 0.69 to 1.61). For late disease the incidence was 0.8% versus 0.6% (1.36, 0.67 to 2.77). Further analysis showed no consistent differences in secondary outcomes.

CONCLUSION:

Daily supplement with vitamin E supplement does not prevent the development or progression of early or later stages of age related macular degeneration.