An observational study in Blepharoptosis, Age-Related Macular Degeneration and Diabetic Macular Edema, sponsored by Abdulkadir Küçük. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Abdulkadir Küçük · Observational
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.
Design: prospective, single-center, longitudinal, non-interventional observational study conducted in the Department of Ophthalmology, University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital, Istanbul, Turkey.
No study-driven intervention is performed. The decision to treat, the anti-VEGF agent (ranibizumab, aflibercept or bevacizumab), the injection interval and the total number of injections are determined solely by the treating retina specialist on clinical grounds. Injections are given under routine sterile conditions, topical anesthesia and with an eyelid speculum, as in standard practice; the study therefore evaluates the combined exposure of injection plus speculum use and cannot isolate the speculum-specific mechanical effect.
The injected eye is the study eye and the non-injected fellow eye is the control eye; each participant serves as their own control. All participants are assessed at baseline and at months 1, 3 and 6. At every visit, for both eyes, MRD-1, MRD-2 and levator function are measured by the same examiner where possible using a standard technique. MRD-1 is the distance in millimetres between the corneal light reflex and the upper eyelid margin in primary gaze; MRD-2 is the distance between the corneal light reflex and the lower eyelid margin; levator function is the upper eyelid excursion from downgaze to upgaze with frontalis action neutralised. The cumulative number of intravitreal injections, the agent used and the number of eyelid speculum uses are recorded at each visit. Clinically significant blepharoptosis is defined as an MRD-1 of 2 mm or less and/or a decrease of 2 mm or more from baseline, evaluated separately for each eye at every visit.
Sample size: based on a paired comparison of the change in MRD-1 at 6 months. Using the 0.43 mm (SD 0.59) MRD-1 reduction at 6 months reported by Bermudez-Castellanos et al., with no significant change in the fellow eyes, and conservatively assuming a between-eye difference of 0.43 mm with a standard deviation of paired differences of 1.00 mm (dz = 0.43), a two-sided alpha of 0.05 and 80% power require a minimum of 45 evaluable participants; allowing for approximately 25% attrition over 6 months, the target enrollment is 60.
Statistical analysis: normality by the Shapiro-Wilk test; between-eye change compared by paired t-test or Wilcoxon signed-rank test; repeated measures across the four timepoints by repeated-measures ANOVA or the Friedman test; frequency of clinically significant blepharoptosis compared between eyes by the McNemar test; associations between the number of injections or speculum uses and the change in eyelid measurements by Pearson or Spearman correlation; a sensitivity analysis compares eyelid measurement change among anti-VEGF agents. Two-sided p \< 0.05 is considered significant. Analyses are performed in SPSS.
75 studies on the registry are indexed under Blepharoptosis; 14 are open to participants now.
This study's planned enrollment of 60 is close to the median of 57 across 16 observational studies indexed under Blepharoptosis.
Browse Blepharoptosis studies →This is the only study on the registry with Abdulkadir Küçük as lead sponsor.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults with a retinal disease starting intravitreal anti-VEGF injections in one eye only. In each participant the injected eye is the study eye and the non-injected fellow eye is the internal control. Both eyes are assessed for MRD-1, MRD-2 and levator function at baseline and at months 1, 3 and 6.
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.
Between-eye difference in the change in margin reflex distance-1 (MRD-1) from baseline to month 6
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 6 in the injected (study) eye is compared with the corresponding change in the non-injected fellow (control) eye.
Time frame: Baseline and 6 months
Between-eye difference in the change in margin reflex distance-2 (MRD-2) from baseline to month 6
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 6 months
Between-eye difference in the change in levator function from baseline to month 6
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 6 months
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 four study visits.
Time frame: Baseline, 1, 3 and 6 months
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: 6 months
Association between cumulative intravitreal injection number and change in eyelid measurements
Correlation between the total number of intravitreal anti-VEGF injections (and the number of eyelid speculum uses) and the change in MRD-1, MRD-2 and levator function in the study eye.
Time frame: 6 months
Change in eyelid measurements by anti-VEGF agent
Sensitivity analysis comparing the change in eyelid measurements among eyes treated with ranibizumab, aflibercept or bevacizumab.
Time frame: 6 months
Plan to share: No — Individual participant data will not be shared publicly. De-identified data may be made available from the principal investigator on reasonable request, subject to institutional and ethics committee approval.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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