Speculum-Free Intravitreal Injection Using Cotton-Tipped Applicator Retraction: A Randomized Trial of Pain, Procedure Time, Patient Satisfaction, and Safety
Starting soon · Not applicable
Conditions studied: Neovascular Age-Related Macular Degeneration (nAMD), Diabetic Macular Edema, Retinal Vein Occlusion, Intravitreal Injections
In brief
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.
Key facts
- Study ID
- NCT07481500
- Run by
- Jakkrit Juhong
- People needed
- 120
- Starts
- 2026-06-01
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2026-03-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Anatomical eyelid abnormality precluding use of either retraction technique
Full record on ClinicalTrials.gov
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