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

ConditionsBlepharoptosisAge-Related Macular DegenerationDiabetic Macular Edema
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAbdulkadir Küçük

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Adults aged 18 years or older with a retinal disease (neovascular age-related macular degeneration, diabetic macular edema or retinal vein occlusion) scheduled to begin intravitreal anti-VEGF therapy in one eye only, with no history of intravitreal injection in either eye, recruited consecutively at a single tertiary ophthalmology clinic in Istanbul, Turkey.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Repeated intravitreal anti-VEGF injection with eyelid speculum

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Patients starting unilateral intravitreal anti-VEGF therapy1 intervention

Trial outcomes

Primary outcomes

1

Between-eye difference in the change in margin reflex distance-1 (MRD-1) from baseline to month 12

MRD-1 (mm) is the distance between the corneal light reflex and the upper eyelid margin in primary gaze. For each patient the change from baseline to month 12 in the injected (study) eye is compared with the corresponding change in the non-injected fellow (control) eye.

Time frame
Baseline and 12 months

Secondary outcomes

1

Between-eye difference in the change in margin reflex distance-2 (MRD-2) from baseline to month 12

MRD-2 (mm) is the distance between the corneal light reflex and the lower eyelid margin. The change in the study eye is compared with the change in the fellow eye.

Time frame
Baseline and 12 months
2

Between-eye difference in the change in levator function from baseline to month 12

Levator function (mm) is the upper eyelid excursion from downgaze to upgaze with frontalis action neutralised. The change in the study eye is compared with the change in the fellow eye.

Time frame
Baseline and 12 months
3

Longitudinal change in MRD-1, MRD-2 and levator function across visits

Change over time in the three eyelid measurements in the study and control eyes across the five study visits.

Time frame
Baseline, 1, 3, 6 and 12 months
4

Incidence of clinically significant blepharoptosis

Proportion of eyes with an MRD-1 of 2 mm or less and/or a decrease of 2 mm or more from baseline, compared between the study eye and the control eye.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abdulkadir Küçük

Lead sponsor

Fatih Sultan Mehmet Training and Research Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: