Table 1.
Inclusion and exclusion criteria for participation in ZEASTRESS-Pilot.
Inclusion criteria | Exclusion criteria |
---|---|
1. White/Caucasian ethnic background of both genders | 1. Ethnic background other than White/Caucasian |
2. Age 50 to 85 years old | 2. Age < 50 years old or > 85 years old |
3. Self-reported normal vision and/or absence of diagnosis of ocular disorders such as glaucoma, AMD, diabetic retinopathy, retinal vascular occlusions, inflammatory eye disorders such as uveitis, retinal detachment in both eyes at examination | 3. Known diagnosis of, or presence at eye examination of inflammatory eye disease (e.g., uveitis, optic neuritis, papillitis), or known diagnosis of autoimmune disease and/or monoclonal gammopathy |
4. Absence of autoimmune disease or monoclonal gammopathy | 4. Body Mass Index (BMI) > 30 |
5. Best corrected visual acuity of 20/25 or better in at least one eye | 5. Best corrected visual acuity < 20/25 in both eyes |
6. Intraocular pressure (IOP) < 25 mmHg | 6. IOP ≥ 25 mmHg in both eyes and/or established diagnosis of, or clear-cut signs of glaucoma |
7. Dilatable pupils in at least one eye | 7. Non-dilatable pupils, or unwillingness to undergo dilated exam |
8. Clear ocular media in at least one eye based on AREDS criteria [45] | 8. Dense media opacities in both eyes |
9. Attached retina in at least one eye | 9. History of current smoking |
10. Ability and willingness to participate in the supplementation study for its entire duration, take the study supplements as directed, and take part in the eye exams and tests planned in the protocol | 10. History of alcohol abuse or drug use |
11. MPOD test-retest variability < 20% between baseline qualification visit 1 (QV1) and QV2 | 11. Use of dietary supplements containing ≥ 250 µg of LT or any amount of ZX (in order to minimize confounding introduced by the intake of other related or overlapping supplements) |