Speculum-Free Intravitreal Injection Using Cotton-Tipped Applicator Retraction: A Randomized Tria… (NCT07481500) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Speculum-Free Intravitreal Injection Using Cotton-Tipped Applicator Retraction: A Randomized Trial of Pain, Procedure Time, Patient Satisfaction, and Safety
120 participantsStarted 2026-06
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. Active ocular infection or inflammation
. Known allergy to povidone-iodine, tetracaine, or levofloxacin
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares two ways of holding the eyelid open during an injection — a speculum versus a cotton-tipped applicator — so if I'm already receiving or about to start intravitreal injections for my condition, is the cotton-tipped method something my doctor already uses, or would joining this trial change how my injections are done?
2Since this trial is measuring pain, procedure time, and patient satisfaction as its main outcomes rather than whether the treatment itself works better, does that mean there's no change to the actual medication being injected into my eye, and my underlying treatment stays exactly the same either way?
3The trial hasn't started recruiting yet — how soon might it open, and given that I may need injections now, should I start standard treatment rather than wait to see if I'd be eligible?
4Because this is a procedural comparison study rather than a drug trial, what are the realistic safety risks specific to trying the cotton-tipped applicator method compared to the speculum I might already be familiar with?
5If I enroll and am randomized to one method but find it more uncomfortable, would I have any option to switch, or would my doctor recommend I just discuss comfort concerns with the care team throughout the study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain Perception
Timeframe: Immediately after intravitreal injection (Day 0)
2
Procedure Duration
Timeframe: During intravitreal injection procedure (Day 0)
3
Patient Satisfaction
Timeframe: 15-30 minutes after intravitreal injection (Day 0)
4
Procedure-Related Complications
Timeframe: Day 0, Day 1, and Week 4 post-injection