Investigation of Macular Pigment Augmentation on Dark Adaptation

Study Overview
=================
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.

Official Title
-----------------
Investigation of Macular Pigment Augmentation on Dark Adaptation

Conditions
-----------------
Aging, Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Dietary Supplement: ZeaVision EyePromise Restore
* Dietary Supplement: Multivitamin


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Comparator<br> | Dietary Supplement: ZeaVision EyePromise Restore<br>* Vitamin C 120mg, Vitamin E 60IU, Zinc 15mg, Fish Oil 250mg, Omega 3 125mg, Alphaliploic acid 10mg, Zeaxanthin 8mg,mixed tocopherols 6mg, lutein 4mg,<br>Dietary Supplement: Multivitamin<br>* Vitamin C 120mg, Vitamin E 60IU, Zinc 15mg, Fish Oil 250mg, Omega 3 125mg, Alphaliploic acid 10mg, mixed tocopherols 6mg, lutein 4mg,<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dark Adaptation |  | Measured 3 times over 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular Pigment Density |  | Measured 3 times over 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aging, age-related macular degeneration, macular pigment, dark adaptation