This randomized controlled trial compares two techniques for eyelid retraction during intravitreal injection (IVI) of anti-VEGF agents: the standard wire eyelid speculum (Group A) versus cotton-tipped applicator retraction (Group B) in patients with neovascular AMD, diabetic macular edema, or retinal vein occlusion.
The study evaluates four outcomes: (1) patient pain perception measured by a 10-cm visual analogue scale immediately after injection; (2) procedure duration from retraction device placement to removal; (3) patient satisfaction assessed by a 5-item Likert scale; and (4) safety including rates of subconjunctival hemorrhage, corneal abrasion, endophthalmitis, and intraocular pressure elevation.
A novel syringe cap technique using the Terumo 31G insulin syringe plastic cap as an injection-site marker (3.5 mm for pseudophakic eyes, 5.0 mm for phakic eyes from the limbus) is employed in both groups, replacing the traditional caliper.
Randomization is stratified by diagnosis and prior injection history using permuted block randomization (block sizes 4 and 6). The target sample size is 120 patients (60 per group) at Walailak University Hospital, Nakhon Si Thammarat, Thailand.
Age 18 years or older
Diagnosed with neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), or retinal vein occlusion (RVO)
Scheduled for intravitreal anti-VEGF injection (bevacizumab, aflibercept, or faricimab)
Able to provide written informed consent
Active ocular infection or inflammation
Known allergy to povidone-iodine, tetracaine, or levofloxacin
Inability to cooperate with the injection procedure
Concurrent participation in another interventional clinical trial
Parallel
Eyelid Speculum Retraction
Procedure/SurgeryA wire eyelid speculum is inserted to retract the eyelids prior to intravitreal anti-VEGF injection (bevacizumab, aflibercept, or faricimab) using a Terumo 31G insulin syringe at the superotemporal quadrant. The speculum is removed immediately after needle withdrawal.
Cotton-Tipped Applicator Retraction
Procedure/SurgeryTwo sterile cotton-tipped applicators are used to retract the eyelids (speculum-free) prior to intravitreal anti-VEGF injection (bevacizumab, aflibercept, or faricimab) using a Terumo 31G insulin syringe at the superotemporal quadrant. Applicators are removed immediately after needle withdrawal.
Pain Perception
Patient-reported pain score measured using a 10-cm visual analog scale (VAS) immediately after the injection procedure, assessed by an independent blinded nurse.
Procedure Duration
Time in seconds from placement of retraction device (speculum or cotton-tipped applicators) to its removal after needle withdrawal, measured by a blinded circulating nurse using a stopwatch.
Patient Satisfaction
Total score on a 5-item Likert satisfaction questionnaire (score range 5-25; higher scores indicate greater satisfaction), administered 15-30 minutes after injection.
Procedure-Related Complications
Incidence of ocular complications including conjunctival hemorrhage, corneal abrasion, vitreous hemorrhage, endophthalmitis, retinal detachment, and elevated intraocular pressure, assessed at Day 0, Day 1 (phone call), and Week 4.
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Jakkrit Juhong
Lead sponsor
Walailak University
Sponsor institution
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