The Zeaxanthin and Visual Function Study

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chrysantis, Inc.
• Collaborators: IMAGE TECHNOLOGIES INC.; Kowa Company, Ltd.

Criteria

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.