An observational study in Age Related Macular Degeneration and Diabetic Macular Edema, sponsored by Augenabteilung Allgemeines Krankenhaus Linz. Completed at 1 site in Austria. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-03-17.
Sponsored by Augenabteilung Allgemeines Krankenhaus Linz · Observational
This prospective study will include patients with neovascular age-related macular degeneration or diabetic macular edema, scheduled for intravitreal aflibercept. Ocular perfusion will be measured by Laser Speckle Flowgraphy (LSFG). The parameter Mean Blur Rate (MBR) reflects erythrocyte flow velocity and serves as an indirect marker of perfusion. MBR will be measured at the optic nerve head (ONH). The devices software can analyze MBR in areas of major retinal vessels (MV) and in microperfusion areas (MT) separately. Measurements will be conducted on the day of the planned intravitreal injection and one and four weeks post-injection.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 36 is below the median of 106 across 421 observational studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Augenabteilung Allgemeines Krankenhaus Linz is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Caucasian patients scheduled for intravitreal Aflibercept because of age related macular degeneration or diabetic macular edema
Exclusion Criteria:
Patients with neovascular age-related macular degeneration, requiring Anti-VEGF
Drug: Intravitreal Aflibercept Injection · Device: Laser speckle flowgraphy
Patients with diabetic macular edema, requiring Anti-VEGF
Drug: Intravitreal Aflibercept Injection · Device: Laser speckle flowgraphy
After instillation of topical anesthesia (0.4% oxybuprocaine hydrochloride and lidocain; own production), sterilization of the eyelid (Betaisodona solution 11% povidone-iodine, Mundipharma, Limburg, Germany), and instillation of 1.25% povidone-iodine drops, 2.0 mg/0.05 mL of aflibercept (Eylea) will be injected into the vitreous cavity through a standard pars plana approach (3.5 mm posterior to the limbus) under sterile conditions.
The RetFlow consists of a fundus camera equipped with a diode laser at a wavelength of 830 nm and a digital charge-coupled device camera (750 x 360 pixels). A total of 118 images are acquired at a rate of 30 frames per second over a 4-second measurement period. The main output parameter of LSFG, mean blur rate (MBR), is calculated from the pattern of speckle contrast produced by the interference of a laser scattered by blood cells moving in the ocular fundus. MBR was calculated for the total ONH area, defined by a ellipsoid region of interest (ROI). By using the on-board software, the MBR will be calculated in the large vessels within the ONH (ONH-MV, "mean MBR of vascular area") and the tissue area containing the microvasculature (ONH-MT, "mean MBR of tissue area")
Mean blur rate in retinal vessels (MV)
With the onboard software, MBR can be calculated in the large vessels within the ONH (ONH-MV, "mean MBR of vascular area")
Time frame: Baseline; Week 1; Week 4;
Plan to share: No
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Augenabteilung Allgemeines Krankenhaus Linz