Wenzhou Dry Age-related Macular Degeneration (AMD) Progression Study
NCT ID: NCT03433885
Last Updated: 2021-02-24
Study Results
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Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2018-01-01
2023-12-31
Brief Summary
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Detailed Description
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The macular pigment (MP) consists of xanthophyll, which is formed from the yellow carotenoid lutein, zeaxanthin, and meso-zeaxanthin.These pigments play an important role in protecting the retina against oxidative stress through different mechanisms\[6\]. Many studies have shown a various association of AMD and MP.Blue Mountain Eye Study revealed low dietary intake of lutein and zeaxanthin is associated with a higher risk of AMD. However, dry and wet subtypes of AMD may have different etiologies and risk factors. Little is known whether longitudinal study of macular pigment optical density (MPOD) is related to AMD progression.
A comprehensive ophthalmologic examination including fundus photography,OCT and MPOD was performed at baseline, and semiannually thereafter for 3 years. Fundus reflectance (VISUCAM 500, reflectance of a single 460 nm wavelength) was used to measure the MPOD levels. Associated risk factors including body-mass index (BMI), smoking, diet, and cardiovascular diseases were documented. Drusen characteristics (size, type, area), pigmentary abnormalities (increased pigment, depigmentation, geographic atrophy), and presence of abnormalities characteristic of neovascular AMD were graded. For estimations of AMD progression , a 9-step severity scale that combines a 6-step drusen area scale with a 5-step pigmentary abnormality scale is used.
In this study, we are going to investigate a 3-year study of incidence and progression for AMD and associated risk factors, in a population-based cohort of Chinese aged 45 years and older living in the city of Wenzhou.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Progressors
Progressors are those individuals with early or intermediate AMD at baseline who progress to advanced AMD during follow-up, and individuals with advanced AMD in one eye at baseline who progress to advanced AMD in both eyes.
No interventions assigned to this group
Nonprogressor
Nonprogressors are those individuals with early or intermediate AMD at baseline who do not progressed to advanced AMD during follow-up, and individuals with advanced AMD in one eye at baseline who do not progress to advanced AMD in fellow eye.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 45 years of age or older
* provides signed and dated informed consent
Exclusion Criteria
* Presence of macular edema like retinal vascular diseases or diabetic retinopathy
* active inflammation ofr infection in the study eye
* high myopia（ ≥6D ）
45 Years
ALL
No
Sponsors
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The Eye Hospital of Wenzhou Medical University
OTHER
Responsible Party
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Xiaoling Liu
Chief in retina center
Principal Investigators
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Xiaoling Liu, MD
Role: PRINCIPAL_INVESTIGATOR
The Eye Hospital of Wenzhou Medical University
Locations
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The eye hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Rong Zhou, MD
Role: primary
References
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Resnikoff S, Pascolini D, Etya'ale D, Kocur I, Pararajasegaram R, Pokharel GP, Mariotti SP. Global data on visual impairment in the year 2002. Bull World Health Organ. 2004 Nov;82(11):844-51. Epub 2004 Dec 14.
Huang EJ, Wu SH, Lai CH, Kuo CN, Wu PL, Chen CL, Chen CY, King YC, Wu PC. Prevalence and risk factors for age-related macular degeneration in the elderly Chinese population in south-western Taiwan: the Puzih eye study. Eye (Lond). 2014 Jun;28(6):705-14. doi: 10.1038/eye.2014.55. Epub 2014 Mar 14.
Ye H, Zhang Q, Liu X, Cai X, Yu W, Yu S, Wang T, Lu W, Li X, Jin H, Hu Y, Kang X, Zhao P. Prevalence of age-related macular degeneration in an elderly urban chinese population in China: the Jiangning Eye Study. Invest Ophthalmol Vis Sci. 2014 Sep 4;55(10):6374-80. doi: 10.1167/iovs.14-14899.
Mitchell P, Smith W, Attebo K, Wang JJ. Prevalence of age-related maculopathy in Australia. The Blue Mountains Eye Study. Ophthalmology. 1995 Oct;102(10):1450-60. doi: 10.1016/s0161-6420(95)30846-9.
Mitchell P, Wang JJ, Foran S, Smith W. Five-year incidence of age-related maculopathy lesions: the Blue Mountains Eye Study. Ophthalmology. 2002 Jun;109(6):1092-7. doi: 10.1016/s0161-6420(02)01055-2.
Yang K, Liang YB, Gao LQ, Peng Y, Shen R, Duan XR, Friedman DS, Sun LP, Mitchell P, Wang NL, Wong TY, Wang JJ. Prevalence of age-related macular degeneration in a rural Chinese population: the Handan Eye Study. Ophthalmology. 2011 Jul;118(7):1395-401. doi: 10.1016/j.ophtha.2010.12.030. Epub 2011 Mar 27.
Schmitz-Valckenberg S, Bultmann S, Dreyhaupt J, Bindewald A, Holz FG, Rohrschneider K. Fundus autofluorescence and fundus perimetry in the junctional zone of geographic atrophy in patients with age-related macular degeneration. Invest Ophthalmol Vis Sci. 2004 Dec;45(12):4470-6. doi: 10.1167/iovs.03-1311.
Johnson EJ, Chung HY, Caldarella SM, Snodderly DM. The influence of supplemental lutein and docosahexaenoic acid on serum, lipoproteins, and macular pigmentation. Am J Clin Nutr. 2008 May;87(5):1521-9. doi: 10.1093/ajcn/87.5.1521.
Tan JS, Wang JJ, Flood V, Rochtchina E, Smith W, Mitchell P. Dietary antioxidants and the long-term incidence of age-related macular degeneration: the Blue Mountains Eye Study. Ophthalmology. 2008 Feb;115(2):334-41. doi: 10.1016/j.ophtha.2007.03.083. Epub 2007 Jul 30.
Lovie-Kitchin J, Feigl B. Assessment of age-related maculopathy using subjective vision tests. Clin Exp Optom. 2005 Sep;88(5):292-303. doi: 10.1111/j.1444-0938.2005.tb06713.x.
Ying GS, Maguire MG, Alexander J, Martin RW, Antoszyk AN; Complications of Age-related Macular Degeneration Prevention Trial Research Group. Description of the Age-Related Eye Disease Study 9-step severity scale applied to participants in the Complications of Age-related Macular Degeneration Prevention Trial. Arch Ophthalmol. 2009 Sep;127(9):1147-51. doi: 10.1001/archophthalmol.2009.189.
Other Identifiers
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kyk20175
Identifier Type: -
Identifier Source: org_study_id
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