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

W

Wenzhou Medical University

Status

Enrolling

Conditions

Macular Pigment Optical Density

Study type

Observational

Funder types

Other

Identifiers

NCT03433885
kyk20175

Details and patient eligibility

About

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

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

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 )

Trial design

300 participants in 2 patient groups

Progressors
Description:
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.
Nonprogressor
Description:
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.

Trial contacts and locations

1

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Central trial contact

Rong Zhou, MD

Data sourced from clinicaltrials.gov

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