Status:
NOT_YET_RECRUITING
Effect of Carotenoids Supplementation on Visual Function in Chinese Subjects
Lead Sponsor:
Zhongshan Ophthalmic Center, Sun Yat-sen University
Collaborating Sponsors:
Blackmores (China) CO., Ltd
Conditions:
Vision Disorders
Eligibility:
All Genders
35+ years
Phase:
NA
Brief Summary
The macula is a pigmented area at the center of the retina, and responsible for the central, high-resolution color vision. Age-related macular degeneration (AMD) is a disease of the macula and is the ...
Eligibility Criteria
Inclusion
- Chinese subjects
- Age 35 years or above
- Monocular BCVA of 6/6 or better
- No more than +/- 5 diopters spherical equivalence of refraction
- No previous consumption of supplements containing macular carotenoids (L, Z and/or MZ) within the last 12 months
- Without severe retinal diseases (eg. retinal detachment, glaucoma, macular hole, idiopathic epiretinal membrane, retinitis pigmentosa, and age-related macular degeneration (assessed by experienced ophthalmologists during ocular examination)
Exclusion
- Unable to provide informed consent
- With diagnosed diabetes
- With severe systemic disease which affects physical mobility and successful follow-up
- Contrast sensitivity at a spatial density of 6 cpd ≤ 1.5 % at baseline in the eye with better visual acuity
- Subjects who plan to receive cataract surgery within the next year
- Subjects who are unable to cooperate with the examinations during follow-ups, such as those who suffer from other serious systemic diseases or mental abnormalities
- History of intraocular surgery (eg. cataract surgery, vitrectomy and retinal laser photocoagulation)
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06098677
Start Date
October 1 2025
End Date
December 31 2025
Last Update
January 28 2025
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