A Cross-sectional Study Exploring the Proteomic Association of Serum Extracellular Vesicles in Patients with Age-related Macular Degeneration and Cognitive Impairment Using LC-MS/MS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- MMSE
Study Overview
Brief Summary
Aim: Preliminary serum exosomal proteomics of patients with dry age-related macular degeneration (AMD) and mild cognitive impairment (MCI) were analyzed using proteomics technology.
Methods: Peripheral serum samples were collected from patients with AMD, MCI, comorbid conditions, and the control group. Exosomes were isolated from these samples and analyzed using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Differentially expressed proteins (DEPs) associated with the two diseases were identified based on fold change and p-value. DEPs were analyzed by Gene Ontology (GO) enrichment, Kyoto Encyclopedia of Genes and Genomes (KEGG), and protein-protein interaction (PPI) network analysis. Western blot and enzyme-linked immunosorbent assay (ELISA) were used to validate the DEPs of interest.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 40 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All dry AMD patients were diagnosed based on the Clinical Classification of Age-Related Macular Degeneration issued by the American Academy of Ophthalmology.
- •All patients with MCI meet the Petersen criteria, including memory impairment, no abnormal cognitive function, dementia, or some cognitive impairment in daily life. A Mini-Mental State Examination (MMSE) score ≥24 points and a Montreal Cognitive Assessment (MoCA) score between 18 and 25 points were required.
Exclusion Criteria
- •The systemic physical exclusion criteria were as follows:(a) Metabolic syndromes such as diabetes or obesity;(b) Uncontrolled hypertension or hypotension;(c) Serious cardiac disease;(d) Neurological diseases, including Parkinson's disease, multiple sclerosis, or peripheral neuropathy;(e) Psychiatric diseases such as hallucinations or depressive disorders;(f) a history of brain injury, stroke, or substance abuse.
- •The ocular exclusion criteria were as follows: (a) intraocular pressure(IOP) > 21 mmHg; (b) axial length(AL) > 25 mm or <22 mm; (c) anterior segment disease affecting fundus examination; (d) retinal pathologic changes associated with high myopia or serious refractive errors (>5D of spherical equivalent refraction or >3D of astigmatism); (e) concomitant ocular diseases, such as glaucoma or retinal detachment; (f) other genetic ocular diseases; and (g) other fundus diseases, including macular hiatus, macular edema, retinal vascular occlusion, or central serous chorioretinopathy.
Outcomes
Primary Outcomes
MMSE
Time Frame: On the first day
Mini-Mental State Examination
Secondary Outcomes
No secondary outcomes reported
Investigators
Sun Yilin
Training physician
Shanghai 10th People's Hospital