Neovascular Age-Related Macular Degeneration (nAMD)IVI-RETRACTNCT07481500
Speculum-Free Intravitreal Injection Using Cotton-Tipped Applicator Retraction: Pain, Procedure Time, Patient Satisfaction, and Safety
A study testing Eyelid Speculum Retraction and Cotton-Tipped Applicator Retraction in people with Neovascular Age-Related Macular Degeneration (nAMD) and Diabetic Macular Edema, run by Jakkrit Juhong at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neovascular Age-Related Macular Degeneration (nAMD), Diabetic Macular Edema, Retinal Vein Occlusion
- What is being tested?
- Eyelid Speculum Retraction and Cotton-Tipped Applicator Retraction
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteThailand
- Study dates
- 9 Sep 2026to 7 Oct 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Walailak University Hospital
Tha Sala, Changwat Nakhon Si Thammarat, 80160
About this study
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
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.
Read the detailed description
Background:
Intravitreal injection is one of the most frequently performed ophthalmic procedures. Eyelid specula are widely used to keep the eye open but may cause discomfort. Cotton-tipped applicator retraction is an alternative that may reduce pain, and when a single applicator is held in one hand, the other hand remains free for injection-site marking and injection, so that one surgeon can complete the procedure without an assistant. Randomized data on procedure duration and satisfaction are limited.
Study Design:
Single-center, prospective, parallel-group randomized controlled trial with 1:1 allocation to an eyelid speculum (Group A) or cotton-tipped applicator retraction (Group B). The principal investigator generated stratified permuted-block sequences (block sizes 4 and 6) with Study Randomizer software; there were six strata: diagnosis (nAMD / DME / RVO) x prior injection history (injection-naive / previously injected). A research assistant placed the assignments in sequentially numbered, opaque, sealed envelopes, which another research assistant opened immediately before each procedure.
Interventions:
One vitreoretinal surgeon performed all injections without an assistant. Injections were given in the superotemporal quadrant in right eyes and the superonasal quadrant in left eyes (surgeon preference, same in both groups). All participants received tetracaine 0.5% and povidone-iodine 5% drops in the waiting area (contact time of at least 5 minutes), povidone-iodine 10% periocular skin preparation, a second instillation of tetracaine, and a fenestrated cloth drape. Anti-VEGF agents (bevacizumab, aflibercept, or faricimab) were prepared by the hospital pharmacy in 1-mL insulin syringes with a fixed 31G needle (Terumo). Group A: adjustable solid-blade eyelid speculum with a screw lock (PMS) retracting the upper and lower eyelids. Group B: one sterile cotton-tipped applicator held in the left hand to retract the upper eyelid; conversion to the speculum if retraction failed after 2 attempts. If the first attempt failed because of forceful eyelid squeezing or a marked Bell phenomenon, the participant was asked to close the eye, the applicator was used to retract the lower eyelid, and the injection was given in the inferotemporal or inferonasal quadrant. The injection site was marked with the povidone-iodine-dipped cap of the insulin syringe. Levofloxacin 0.5% was instilled after injection.
Outcome Measures:
All four outcomes are primary. Pain (0-10 numbered pain scale with faces), procedure duration (seconds), and satisfaction (5-item Likert questionnaire, total 5-25) were assessed on Day 0, 1-5 minutes after injection. Safety outcomes were assessed on Day 0, Day 1 (telephone), and Week 4 (clinic visit). Pain, procedure duration, and satisfaction are tested at a Bonferroni-adjusted alpha of 0.0167; safety is summarized descriptively (statistical analysis plan version 1.0, locked September 21, 2026).
Masking:
Open label. Participants, the surgeon, and the research assistants who timed the procedure and assessed the outcomes were aware of group assignment.
Sample Size:
Based on Chen et al. (2025) (pooled SD 1.71 for pain; Cohen's d = 0.57), with alpha = 0.025 (Bonferroni correction for 2 outcomes) and 80% power, 60 patients per group are required for pain (the earlier version of this record reported 52 per group because of a calculation error) and 46 per group for procedure duration. The enrollment target was 60 per group (120 total). All eligible patients who attended the injection session and gave consent were randomized (actual enrollment, 129).
- Conditions
- Neovascular Age-Related Macular Degeneration (nAMD), Diabetic Macular Edema, Retinal Vein Occlusion, Intravitreal Injections, Polypoidal Choroidal Vasculopathy
- Being tested
- Eyelid Speculum Retraction, Cotton-Tipped Applicator Retraction
- Keywords
- intravitreal injection, eyelid speculum, cotton-tipped applicator, injection pain, procedure time, patient satisfaction, anti-VEGF, randomized controlled trial
- Medical subject headings
- Retinal Vein Occlusion, Polypoidal Choroidal Vasculopathy, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eyelid Speculum RetractionProcedure or surgery
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 RetractionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Eyelid Speculum (Group A) | Active comparator | Intravitreal injection performed with an adjustable solid-blade eyelid speculum with a screw lock (PMS) retracting the upper and lower eyelids. The speculum is inserted immediately before injection-site marking and injection and removed immediately after needle withdrawal. Receives: Procedure: Eyelid Speculum Retraction |
| Cotton-Tipped Applicator (Group B) | Experimental | A single sterile cotton-tipped applicator, held in the surgeon's left hand, retracts the upper eyelid (speculum-free) 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). 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. Receives: Procedure: Cotton-Tipped Applicator Retraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Perception
Patient-reported pain score on a 0-10 numbered pain scale with a faces pictogram and verbal categories (0 = no pain; 10 = worst pain). The participant pointed to or stated a level, and a research assistant recorded the score after the participant had left the injection room.
Measured: 1-5 minutes after intravitreal injection (Day 0)
Procedure Duration
Time in seconds from the first contact of the retraction device (speculum or cotton-tipped applicator) with the eyelid to its complete removal after needle withdrawal, measured by a research assistant with a stopwatch.
Measured: During intravitreal injection procedure (Day 0)
Patient Satisfaction
Total score on a 5-item Likert satisfaction questionnaire in Thai (item 3, squeezing or pressure on the eyelid, reverse-scored; total 5-25; higher scores indicate greater satisfaction), administered at the same assessment as the pain score.
Measured: 1-5 minutes after intravitreal injection (Day 0)
Procedure-Related Complications
Incidence of ocular complications, including subconjunctival hemorrhage, corneal abrasion, lens touch, vitreous hemorrhage, endophthalmitis, rhegmatogenous retinal detachment, and intraocular pressure greater than 25 mmHg, assessed on Day 0 (clinic), Day 1 (telephone call), and Week 4 (clinic visit).
Measured: Day 0, Day 1, and Week 4 post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start9 Sep 2026
- Primary completion7 Oct 2026 (estimated)
- Study completion7 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neovascular Age-Related Macular Degeneration (nAMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomized 1:1 to either eyelid speculum retraction (Group A) or cotton-tipped applicator retraction (Group B) for intravitreal injection. Stratified by diagnosis (nAMD, DME, RVO) and prior injection history (naive, previously injected) using permuted block randomization with variable block sizes of 4 and 6.
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jakkrit Juhong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jakkrit Juhong, Walailak University
- Investigators
- Jakkrit Juhong, MD, Principal investigator, Walailak University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481500
- Sponsor's protocol ID
- WURCT5954
- Acronym
- IVI-RETRACT
- Status last verified
- Sep 2026
- First submitted
- 13 Mar 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the article (baseline characteristics, pain, procedure duration, satisfaction, and adverse events), with a data dictionary, will be shared on reasonable request to the principal investigator.
Publications
Chen HRQ, de Andrade GC, Arimori LK, Lerner FK. Comparison of intravitreal injection techniques with and without a speculum using eyelid retraction with a cotton-tipped applicator. Int J Retina Vitreous. 2025 Oct 29;11(1):119. doi: 10.1186/s40942-025-00739-5.
PubMed 41163036