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Wenzhou Dry Age-related Macular Degeneration (AMD) Progression Study

Progression of Dry Age-related Macular Degeneration (AMD): Association With Macular Pigment Optical Density (MPOD)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03433885
Enrollment
300
Registered
2018-02-15
Start date
2018-01-01
Completion date
2023-12-31
Last updated
2021-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Pigment Optical Density

Keywords

macular pigment optical density (MPOD), Age-related Macular Degeneration (AMD), drusen, Chroidal neovascularization (CNV), lutein, zeaxanthin

Brief summary

To evaluate the correlation between macular pigment optical density (MPOD) levels and risk of progression in patients with age-related macular degeneration

Detailed description

Age-related macular degeneration (AMD) is the leading cause of blindness in the elderly.\[1\] The disease is categorized into early, intermediate, or advanced stages based on the severity of symptoms. The advanced stage, including GA and CNV, involves central region of the retina, which leads to a gradual or rapid loss of photoreceptors and central vision. 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.

Interventions

None listed

Sponsors

The Eye Hospital of Wenzhou Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* subject is diagnosed with either CNV, dry AMD * 45 years of age or older * provides signed and dated informed consent

Exclusion criteria

* Ocular condition in the study eye which may impact vision and confound study outcomes * Presence of macular edema like retinal vascular diseases or diabetic retinopathy * active inflammation ofr infection in the study eye * high myopia( ≥6D )

Design outcomes

Primary

MeasureTime frameDescription
Association between changes of macular pigment optical density (MPOD) level and incidence rates of advanced AMDfrom baseline to month 36Incident advanced AMD was evaluated based on the AMD grade at the end of the clinical trial with follow-up time of 3 years. Progressors were those individuals with early or intermediate AMD at baseline who progressed to advanced AMD during follow-up, and individuals with advanced AMD in one eye at baseline who progressed to advanced AMD in both eyes

Secondary

MeasureTime frameDescription
Association between age and incident Advanced AMDbaselinecontrolling for age (70 years or older versus younger than 70)
Association between gender and incident Advanced AMDbaseline
Association between Baseline AMD grade and incident Advanced AMDbaselineBaseline AMD grade was defined as AREDS category 1 in both eyes (essentially free of age-related macular abnormalities), category 2 in the worst eye (mild changes including multiple small drusen, nonextensive intermediate drusen, and/or pigment abnormalities), category 3 in the worst eye (at least one large drusen of at least 125µm diameter, extensive intermediate drusen, and/or noncentral geographic atrophy), category 4 in one eye (advanced AMD, either neovascular or central geographic atrophy, or visual loss due to AMD regardless of phenotype), or category 4 in both eyes.
Association between cigarette smoking and incident Advanced AMDbaselinecigarette smoking information was acquired by questionaires(never, past, or current) .
Association between body mass index (BMI) and incident Advanced AMDbaselineBMI was calculated as the weight in kilograms divided by the square of the height in meters ( 25, 25-29.9, and 30 )

Countries

China

Contacts

Primary ContactRong Zhou, MD
zhourongmoon@163.com86-577-88068855

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026