The Zeaxanthin and Visual Function Study (ZVF)

Chrysantis

Status: Completed

Conditions: Age Related Macular Degeneration; Cognition Disorders

Treatments: Dietary Supplement: Lutein; Dietary Supplement: Lutein and Zeaxanthin; Drug: 3R 3'R Zeaxanthin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00564902

CHRY1

IRB 07-046 (Other Identifier)

Details and patient eligibility

About

To evaluate if supplementation of zeaxanthin (with or without Lutein) is beneficial to patients with early and moderate Atrophic Age Related Macular Degeneration.

Full description

To evaluate whether or not zeaxanthin supplementation raises macular pigment optical density (MPOD). Previous research has shown MPOD to mirror visual benefits for patients with age related atrophic macular degeneration (AMD) having visual symptoms (decreased visual acuity, contrast sensitivity, photostress glare recovery and National Eye Institute Visual Function Questionnaire 25 scores), but lower risk National Eye Institute (NEI) / Age Related Eye Disease Study (AREDS) characteristics.

Enrollment: 60 patients

Sex: All

Ages: 45 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of atrophic AMD (ICD9 362.51) by stereo bio-ophthalmoscopy and at least one vision degrading visual-psychophysical abnormality associated with AMD in one or both eyes.
• clear non-lenticular ocular media (cornea, aqueous and vitreous)
• free of advanced glaucoma and diabetes or any other ocular or systemic disease that could affect central or parafoveal macula visual function

Exclusion criteria

• high risk retinal characteristics for advanced AMD or advanced AMD for which existing medical / surgical options are available
• presence of ophthalmologically significant active exudative, AMD pathology by fluorescein angiography but also a single large drusen, >15, multiple intermediate drusen, parafoveal geographic atrophy or loss of vision in one eye due to advanced AMD
• recent (within 6 months) cataract or retinal surgery
• taking photosensitizing drugs such as phenothiazines and chloroquine
• having taken lutein or zeaxanthin supplements within the past six months.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

Lutein

Placebo Comparator group

Description:

9 mg of Lutein for 12 months

Treatment:

Dietary Supplement: Lutein

Zeaxanthin and Lutein

Active Comparator group

Description:

3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months

Treatment:

Dietary Supplement: Lutein and Zeaxanthin

Zeaxanthin

Active Comparator group

Description:

3R 3'R Zeaxanthin 8 mg per day during 12 months

Treatment:

Drug: 3R 3'R Zeaxanthin