NCT07481500Active, not recruiting
Speculum-Free Intravitreal Injection Using Cotton-Tipped Applicator Retraction: Pain, Procedure Time, Patient Satisfaction, and Safety
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
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 129 (actual)
- First submitted
- 13 Mar 2026
- Start date
- 9 Sept 2026
- Primary completion date
- 7 Oct 2026
- Lead sponsor
- Jakkrit Juhong
- Diseases
- Macular degeneration, Diabetic eye disease
- NCT number
- NCT07481500
What you commit to
- Study type: Interventional
- Participants enrolled: 129
- From 9 Sept 2026 to the primary completion date, 7 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in another interventional clinical trial
Other illness
- Active ocular infection or inflammation
- Known allergy to povidone-iodine, tetracaine, or levofloxacin
Other
- Inability to cooperate with the injection procedure
- Anatomical eyelid abnormality precluding use of either retraction technique
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Walailak University Hospital Coordinator of this site? Confirm its status | Tha Sala | Thailand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.