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Blepharoptosis After Repeated Intravitreal Anti-VEGF Injections: A Prospective Study

StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
Intravitreal anti-VEGF injections are a mainstay of treatment for retinal diseases such as neovascular age-related macular degeneration, diabetic macular edema and retinal vein occlusion, and usually require repeated administration over years. During each injection an eyelid speculum holds the lids open and the upper eyelid is exposed to repeated mechanical stretch. Aponeurotic ptosis after intraocular surgery is well described, but evidence on blepharoptosis after repeated intravitreal injections is limited and conflicting. This single-center prospective observational study enrolls 60 patients who are starting intravitreal anti-VEGF therapy in one eye only; the untreated fellow eye of each patient serves as an internal control. Upper eyelid position and function are assessed with margin reflex distance-1 (MRD-1), margin reflex distance-2 (MRD-2) and levator function at baseline and at months 1, 3, 6 and 12. The primary endpoint is the difference between the injected eye and the fellow eye in the change in MRD-1 from baseline to month 12.
Trial Details
NCT Number NCT07821450
Lead Sponsor Abdulkadir Küçük
Conditions
(from sponsor)
Blepharoptosis, Age-Related Macular Degeneration, Diabetic Macular Edema
Related terms Blepharoptosis, Macular Degeneration
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov