Speculum-Free Intravitreal Injection Using Cotton-Tipped Applicator Retraction: Pain, Procedure Time, Patient Satisfaction, and Safety

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.

Inclusion Criteria: 1. Age 18 years or older 2. Diagnosed with neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), or retinal vein occlusion (RVO) 3. Scheduled for intravitreal anti-VEGF injection (bevacizumab, aflibercept, or faricimab) 4. Able to provide written informed consent Exclusion Criteria: 1. Active ocular infection or inflammation 2. Known allergy to povidone-iodine, tetracaine, or levofloxacin 3. Inability to cooperate with the injection procedure 4. Concurrent participation in another interventional clinical trial 5. Anatomical eyelid abnormality precluding use of either retraction technique