Wenzhou Dry Age-related Macular Degeneration (AMD) Progression Study
Cuvinte cheie
Abstract
Descriere
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.
Datele
| Ultima verificare: | 06/30/2019 |
| Primul depus: | 01/29/2018 |
| Inscriere estimată trimisă: | 02/07/2018 |
| Prima postare: | 02/14/2018 |
| Ultima actualizare trimisă: | 07/16/2019 |
| Ultima actualizare postată: | 07/17/2019 |
| Data actuală de începere a studiului: | 12/31/2017 |
| Data estimată de finalizare primară: | 12/30/2020 |
| Data estimată de finalizare a studiului: | 12/30/2023 |
Stare sau boală
Fază
Grupuri de brațe
| Braţ | Intervenție / tratament |
|---|---|
| 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. | |
| 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. |
Criterii de eligibilitate
| Vârste eligibile pentru studiu | 45 Years La 45 Years |
| Sexe eligibile pentru studiu | All |
| Metoda de eșantionare | Non-Probability Sample |
| Acceptă voluntari sănătoși | da |
| Criterii | 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 ） |
Rezultat
Măsuri de rezultate primare
1. Association between changes of macular pigment optical density (MPOD) level and incidence rates of advanced AMD [from baseline to month 36]
Măsuri de rezultate secundare
1. Association between age and incident Advanced AMD [baseline]
2. Association between gender and incident Advanced AMD [baseline]
3. Association between Baseline AMD grade and incident Advanced AMD [baseline]
4. Association between cigarette smoking and incident Advanced AMD [baseline]
5. Association between body mass index (BMI) and incident Advanced AMD [baseline]
