Investigation of Macular Pigment Augmentation on Dark Adaptation

Phase 4

Terminated

• Conditions: Age-Related Macular Degeneration; Aging
• Interventions: Dietary Supplement: ZeaVision EyePromise Restore; Dietary Supplement: Multivitamin

• Registration Number: NCT00478439
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study First Submitted: 2007-05-22
• Study First Submitted QC: 2007-05-22
• Study First Posted: 2007-05-24
• Study Start: 2007-12
• Primary Completion: 2009-09
• Status Verified: 2010-10
• Study Completion: 2010-10
• Last Update Submitted: 2010-10-26
• Last Update Posted: 2010-10-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator	ZeaVision EyePromise Restore	-
Placebo Comparator	Multivitamin	-

Primary Outcome Measures

Name	Time	Method
Dark Adaptation	Measured 3 times over 8 months

Secondary Outcome Measures

Name	Time	Method
Macular Pigment Density	Measured 3 times over 8 months

Trial Locations

Locations (1)

UAB School of Optometry; 🇺🇸 Birmingham, Alabama, United States