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NCT07821450

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

Sponsor: Abdulkadir Küçük

View on ClinicalTrials.gov

Summary

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.

Official title: Prospective Evaluation of Blepharoptosis Development in Patients Undergoing Repeated Intravitreal Anti-VEGF Injections

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2026-09-25

Completion Date

2028-01-05

Last Updated

2026-09-15

Healthy Volunteers

No

Interventions

OTHER

Repeated intravitreal anti-VEGF injection with eyelid speculum

Intravitreal anti-VEGF injection (ranibizumab, aflibercept or bevacizumab) given in the study eye on clinical indication under sterile conditions, topical anesthesia and with an eyelid speculum. Agent, interval and number of injections are determined by the treating retina specialist, not by the study.

Locations (1)

University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Turkey (Türkiye)