None listed
Conditions
Interventions
Control group:Except for not adding lutein esters and zeaxanthin, all other components (such as the matrix, taste, and colour) are identical to those in the intervention group.
Intervention group:Intervention group beverage: 10ml per serving, containing 6mg lutein esters and 1.2mg zeaxanthin.Two servings were consumed daily.
Sponsors
the First Affiliated Hospital of Xi 'an Jiaotong University
Eligibility
Sex/Gender
All
Age
4 Years to 12 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria: 1. Aged 4 to 12 years inclusive, with no gender restrictions. 2. Ciliary muscle paralysis (e.g. with tropicamide) computerised refraction, the equivalent spherical power of both eyes must fall between -1.00D and -5.00D inclusive. 3. Bilateral astigmatism = 0.8 in either eye (using the ETDRS chart). 6. No amblyopia or organic ocular disease (e.g., cataract, glaucoma, macular degeneration, retinal disorders) in either eye. 7. The subject and their legal guardian fully understand the study content, participate voluntarily, and sign a written Informed Consent Form. 8. The legal guardian is capable and willing to cooperate with study protocol requirements including visits, questionnaire completion, and administration of intervention agents.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria shall be excluded from the study: 1. Presence of ocular disease affecting vision or refractive error (such as the aforementioned organic lesions). 2. Accompanied by uncontrolled ocular or systemic infectious diseases, or accompanied by active ocular inflammation. 3. Undergone ocular surgery or laser treatment within the preceding six months. 4. Regular intake of dietary supplements containing lutein or zeaxanthin within the past three months. 5. Known allergy to any component of the study beverage. 6. Strict vegetarians or individuals with severe dietary restrictions or selective eating habits, judged by the investigator to potentially influence study outcomes. 7. Concurrent participation in any other interventional clinical trial. 8. Any other condition deemed by the investigator to render the subject unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acular pigment optical densit; | — |
Secondary
| Measure | Time frame |
|---|---|
| Contrast sensitivity;Glare sensitivity;Macular foveal thickness;Eye strain score;Duration of clear vision;Visual reaction time;Axial length of the eye; | — |
Countries
China
Contacts
Public ContactJiang hong
the First Affiliated Hospital of Xi 'an Jiaotong University
Outcome results
None listed