The study investigates inflammatory processes in various eye diseases: keratoconus, age-related macular degeneration (AMD), diabetic macular edema (DME), central serous chorioretinopathy (CSC), as well as cataract (used as a comparison group). The aim is to identify immunological differences between these conditions. ICD-10 Codes: H18.6 – Keratoconus H35.3 – Age-related macular degeneration (AMD) E14.3 – Diabetic macular edema (DME) (Diabetes mellitus with ophthalmic complications, unspecifi
Conditions
Interventions
Group 1: Non-interventional observational study:
Patients with ocular diseases (age-related macular degeneration [AMD], diabetic macular edema [DME], keratoconus [KK], central serous chorioretinopathy
Sponsors
Klinik für Augenheilkunde, Universitätsklinikum des Saarlandes UKS
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age over 18 years 2. Written informed consent given by the participant or their legal representative 3. Presence of one of the following diagnosed eye diseases: Kerotoconus (KK) - Age-related macular degeneration (AMD) - Diabetic macular edema (DME) - Central serous chorioretinopathy (CCS) - Cataract
Exclusion criteria
Exclusion criteria: 1. Lack of consent or inability to consent without a legal guardian. 2. Pregnancy. 3. Pre-existing eye diseases diagnosed by an ophthalmologist that could cause inflammation, such as uveitis or scleritis. 4. Prior keratoplasty in keratoconus patients. 5. Previous intravitreal injection therapy (IVOM) and other retinal diseases in AMD and DME patients. 6. Other retinal diseases in CCS patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Quantitative determination of concentrations of specific inflammatory biomarkers (e.g., IL-1ß, IL-6, TNF-a, VEGF, among others) using multiplex analysis (Legendplex) in serum and aqueous humor samples (collected during planned medical procedures such as keratoplasty surgery or intravitreal injection) from patients with cataract, keratoconus, AMD, cataract (DMÖ), and CCS. Single measurement in patients with cataract, keratoconus, and CCS during the planned medical procedure. Measurement of parameters during the first and second intravitreal injections in patients with DMÖ and AMD. - Comparison of biomarker concentrations between the different disease groups and the control group (patients with cataract). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Correlation of biomarker concentrations with clinical parameters such as disease stage and diagnostic parameters from imaging techniques including macular OCT, optic nerve head OCT, Pentacam, and OCT angiography, particularly with regard to pathological changes that correlate with inflammatory parameters. - Follow-up monitoring of biomarker levels in AMD and cataract (DMÖ) patients undergoing a second intravitreal injection. | — |
Countries
Germany
Contacts
Public ContactViola Katharina Merk
Klinik für Augenheilkunde, Universitätsklinikum des Saarlandes UKS
Outcome results
None listed