Investigation of Macular Pigment Augmentation on Dark Adaptation

The University of Alabama at Birmingham

Status and phase: Terminated; Phase 4

Conditions: Aging; Age-Related Macular Degeneration

Treatments: Dietary Supplement: ZeaVision EyePromise Restore; Dietary Supplement: Multivitamin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00478439

F070410002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

13 participants in 1 patient group, including a placebo group

Placebo Comparator

Placebo Comparator group

Treatment:

Dietary Supplement: ZeaVision EyePromise Restore

Dietary Supplement: Multivitamin