Change in Ocular Perfusion After Intravitreal Anti-VEGF in Patients with Age-related Maculopathy or Diabetic Macula Edema

Sponsor
Augenabteilung Allgemeines Krankenhaus Linz
Study ID
NCT06878573
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intravitreal Aflibercept Injection — DRUG
    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.
  • Laser speckle flowgraphy — DEVICE
    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")

Study Details

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.

Key Dates

Start date
Nov 22, 2023
Status verified
Mar 2025
Primary completion
Jun 29, 2024
Completion
Jul 30, 2024

Study Design

Enrollment
36 participants (actual)

Arms

  • Arm: Age-related macular degeneration
    Patients with neovascular age-related macular degeneration, requiring Anti-VEGF
  • Arm: Patients with diabetic macular edema
    Patients with diabetic macular edema, requiring Anti-VEGF

Primary Outcome Measure

Mean blur rate in retinal vessels (MV) [ Time Frame: Baseline; Week 1; Week 4; ]

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