DRKS00023860
Not Yet Recruiting
N/A
Investigation of genetic and non-genetic biomarkers in the aqueous humor of the eye in various diseases of the eye (age-related macular degeneration, diabetic macular edema and glaucoma) in comparison with controls.
Zentrum für Augenheilkunde Uniklinik Köln0 sites300 target enrollmentDecember 14, 2020
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- H35.3
- Sponsor
- Zentrum für Augenheilkunde Uniklinik Köln
- Enrollment
- 300
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •For participants with wet AMD or DME, only one eye can be selected as the study eye. The study eye is the eye dedicated to the anti\-VEGF injection. If both eyes are treated with anti\-VEGF, the study eye with the shortest anti\-VEGF treatment history will be (if otherwise the same, the right eye is the study eye).
- •Participants can only participate in the study if all of the following criteria are met:
- •All participants (cataract, glaucoma, wetAMD and DME):
- •1\. Written declaration of consent and compliance with the study protocol in accordance with the International Conference on Harmonization (ICH) and local regulations. Alternatively, a legally authorized representative must be able to give the patient's consent in accordance with ICH and local regulations.
- •2\. Participants for whom a sampling of\> 90 µl aqueous humor appears feasible and safe in the opinion of the examiner
- •Participants with cataracts:
- •1\. Male and female participants aged 45 and over with age\-related cataracts
- •2\. The participant's study eye is intended for cataract surgery
- •Participants with glaucoma:
- •1\. Male and female participants aged 18 and over with a diagnosed glaucoma
Exclusion Criteria
- •Participants will be excluded from the study if any of the following criteria are met:
- •Ocular diseases (all participants):
- •1\. Eye history of retinal (focal, pan\- or macular) laser photocoagulation within the last three months in the study eye (for AMD: Participants with a history of central macular laser photocoagulation in the study eye are not permitted)
- •2\. History of a laser iridotomy or YAG laser capsulotomy within the last month in the study eye
- •3\. History of vitreoretinal surgery / pars plana vitrectomy in the study eye
- •4\. Neovascularization of the iris in the examination eye
- •5\. Participants with a systemic autoimmune disease
- •Previous / accompanying therapy (all participants):
- •1\. Any treatment of diseases of the dry eye in the last month before the aqueous humor (AH) sampling (except for the lubrication of eye drops and ointments) in the examination eye
- •2\. Any treatment with intraocular or periocular steroids within the last 6 months prior to the AH sampling in the examination eye
Outcomes
Primary Outcomes
Not specified
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