Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT00564902
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
90 Years
Study:
NCT00564902
Study Brief:
Protocol Section:
NCT00564902