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Speculum-Free Intravitreal Injection Using Cotton-Tipped Applicator Retraction: Pain, Procedure Time, Patient Satisfaction, and Safety
Sponsor: Jakkrit Juhong
Summary
This randomized controlled trial compares two techniques for eyelid retraction during intravitreal injection (IVI): an adjustable solid-blade eyelid speculum (Group A) and single-hand retraction of the upper eyelid with one cotton-tipped applicator (Group B), in patients with neovascular age-related macular degeneration (including polypoidal choroidal vasculopathy), diabetic macular edema, or retinal vein occlusion treated at Walailak University Hospital, Nakhon Si Thammarat, Thailand. The study evaluates four outcomes: (1) pain on a 0-10 numbered pain scale with a faces pictogram, 1-5 minutes after injection; (2) procedure duration from the first contact of the retraction device with the eyelid to its removal; (3) patient satisfaction on a 5-item Likert questionnaire; and (4) safety, including subconjunctival hemorrhage, corneal abrasion, lens touch, vitreous hemorrhage, endophthalmitis, retinal detachment, and intraocular pressure elevation. In both groups, the cap of the insulin syringe is used as an injection-site marker instead of a caliper. Randomization was stratified by diagnosis and prior injection history using permuted blocks of 4 and 6. All 129 participants were randomized and injected on September 9, 2026.
Official title: Speculum-Free Intravitreal Injection Using Cotton-Tipped Applicator Retraction: A Randomized Controlled Trial Comparing Pain Perception, Procedure Duration, Patient Satisfaction, and Safety Between Eyelid Speculum and Cotton-Tipped Applicator Retraction Techniques
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
129
Start Date
2026-09-09
Completion Date
2026-10-07
Last Updated
2026-09-25
Healthy Volunteers
No
Conditions
Interventions
Eyelid Speculum Retraction
An adjustable solid-blade eyelid speculum with a screw lock (PMS) is inserted to retract the upper and lower eyelids before intravitreal injection (bevacizumab, aflibercept, or faricimab) with a Terumo 31G insulin syringe in the superotemporal quadrant in right eyes or the superonasal quadrant in left eyes (surgeon preference, same in both groups). The speculum is removed immediately after needle withdrawal.
Cotton-Tipped Applicator Retraction
One sterile cotton-tipped applicator, held in the surgeon's left hand, is used to retract the upper eyelid (speculum-free) before intravitreal anti-VEGF injection (bevacizumab, aflibercept, or faricimab) with a Terumo 31G insulin syringe in the superotemporal quadrant in right eyes or the superonasal quadrant in left eyes (surgeon preference, same in both groups). The right hand marks the injection site and injects. If the first attempt fails because of forceful eyelid squeezing or a marked Bell phenomenon, the participant is asked to close the eye, the applicator is used to retract the lower eyelid, and the injection is given in the inferotemporal or inferonasal quadrant. The eyelid speculum is used if retraction fails after 2 attempts. The applicator is removed immediately after needle withdrawal.
Locations (1)
Walailak University Hospital
Tha Sala, Changwat Nakhon Si Thammarat, Thailand