NCT07821450 Blepharoptosis After Repeated Intravitreal Anti-VEGF Injections: A Prospective Study

Eligibility & Interventions

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 60 participants in total. It began in 2026-09-25 with a primary completion date of 2027-06-25.

Brief 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 and 6. The primary endpoint is the difference between the injected eye and the fellow eye in the change in MRD-1 from baseline to month 6.

Eligibility Criteria

Inclusion Criteria: * Age 18 years or older * Planned initiation of intravitreal anti-VEGF injection in one eye only for a retinal disease * No prior intravitreal injection in either eye * Able to attend the scheduled follow-up visits and to cooperate for the duration of the study * Reliable MRD-1, MRD-2 and levator function measurement possible in both eyes (clear corneal light reflex, clearly visible eyelid margin, able to maintain primary gaze) * Signed informed consent Exclusion Criteria: * Pre-existing blepharoptosis or significant eyelid malposition at the baseline examination * Previous ptosis surgery, blepharoplasty or other eyelid surgery that may affect upper eyelid anatomy * History of myasthenia gravis, oculomotor nerve palsy, Horner syndrome, facial nerve palsy or a similar neurologic or neuromuscular disorder * History of orbital trauma, orbital surgery or orbital disease * Advanced dermatochalasis, eyelid retraction, entropion, ectropion or marked facial asymmetry precluding reliable eyelid measurement * Need for intravitreal injection in both eyes during the study period * Ocular or periocular surgery during follow-up that may affect upper eyelid position * Inability to comply with follow-up visits or incomplete measurements * Withdrawal of consent * Inability to obtain reliable eyelid measurements due to severe blepharospasm, advanced corneal opacity, marked eyelid edema, or inability to maintain head or neck position or to cooperate

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