Investigation of Macular Pigment Augmentation on Dark Adaptation

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00478439

Enrollment

Registered

2007-05-24

Start date

2007-12-31

Completion date

2010-10-31

Last updated

2010-10-27

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

Conditions

Age-Related Macular Degeneration, Aging

Keywords

aging, age-related macular degeneration, macular pigment, dark adaptation

Brief summary

The study will evaluate whether taking a nutritional supplement designed to increase macular pigment in the eye can improve a person's ability to adjust to darkness. Patients will be assigned to take either a placebo or nutritional supplement for 8 months. Vision will be assessed at baseline, 4 months, and 8 months.

Detailed description

The study design is a randomized, double-blinded, placebo-controlled intervention study that will evaluate whether macular pigment augmentation improves the speed of dark adaptation. Two groups of participants will be enrolled, old adults with normal vision and early age-related macular degeneration patients. Macular pigment will be augmented using EyePromise RESTORE (ZeaVision, Inc). EyePromise RESTORE is a nutritional supplement that has been found to increase macular pigment levels in some users. Macular pigment level and the speed of dark adaptation (how fast a person adjusts to the dark) will be assessed at baseline, 4-months, and 8-months. Fundus appearance will be assessed at baseline and 8-months follow-up.

Interventions

DIETARY_SUPPLEMENTZeaVision EyePromise Restore

Vitamin C 120mg, Vitamin E 60IU, Zinc 15mg, Fish Oil 250mg, Omega 3 125mg, Alphaliploic acid 10mg, Zeaxanthin 8mg,mixed tocopherols 6mg, lutein 4mg,

DIETARY_SUPPLEMENTMultivitamin

Vitamin C 120mg, Vitamin E 60IU, Zinc 15mg, Fish Oil 250mg, Omega 3 125mg, Alphaliploic acid 10mg, mixed tocopherols 6mg, lutein 4mg,

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

60 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* 60 to 80 years old * \< +- 4.00 diopters spherical equivalent * normal eye health or early age-related macular degeneration

Exclusion criteria

* neurological conditions that can impair vision * diabetes

Design outcomes

Primary

Measure	Time frame
Dark Adaptation	Measured 3 times over 8 months

Secondary

Measure	Time frame
Macular Pigment Density	Measured 3 times over 8 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026