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

NCT07481500 | Not Yet Recruiting

• 1 other identifier: WURCT5954
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Neovascular Age-Related Macular Degeneration (nAMD); Diabetic Macular Edema; Retinal Vein Occlusion; Intravitreal Injections

Keywords

intravitreal injection; eyelid speculum; cotton-tipped applicator; injection pain; procedure time; patient satisfaction; anti-VEGF; randomized controlled trial

Outcome Measures

Primary Outcomes (4)

• Pain Perception

  Patient-reported pain score measured using a 10-cm visual analog scale (VAS) immediately after the injection procedure, assessed by an independent blinded nurse.

  Immediately after intravitreal injection (Day 0)

• Procedure Duration

  Time in seconds from placement of retraction device (speculum or cotton-tipped applicators) to its removal after needle withdrawal, measured by a blinded circulating nurse using a stopwatch.

  During intravitreal injection procedure (Day 0)

• Patient Satisfaction

  Total score on a 5-item Likert satisfaction questionnaire (score range 5-25; higher scores indicate greater satisfaction), administered 15-30 minutes after injection.

  15-30 minutes after intravitreal injection (Day 0)

• Procedure-Related Complications

  Incidence of ocular complications including conjunctival hemorrhage, corneal abrasion, vitreous hemorrhage, endophthalmitis, retinal detachment, and elevated intraocular pressure, assessed at Day 0, Day 1 (phone call), and Week 4.

  Day 0, Day 1, and Week 4 post-injection

Study Arms (2)

Eyelid Speculum (Group A)

ACTIVE COMPARATOR

Intravitreal anti-VEGF injection performed using a wire eyelid speculum for eyelid retraction. The speculum is inserted immediately before injection and removed immediately after needle withdrawal.

Procedure: Eyelid Speculum Retraction

Cotton-Tipped Applicator (Group B)

EXPERIMENTAL

Speculum-free intravitreal anti-VEGF injection using two sterile cotton-tipped applicators for eyelid retraction. Applicators are placed on the upper and lower eyelid margins immediately before injection and removed immediately after needle withdrawal.

Procedure: Cotton-Tipped Applicator Retraction

Interventions

Eyelid Speculum Retraction PROCEDURE

A wire eyelid speculum is inserted to retract the eyelids prior to intravitreal anti-VEGF injection (bevacizumab, aflibercept, or faricimab) using a Terumo 31G insulin syringe at the superotemporal quadrant. The speculum is removed immediately after needle withdrawal.

Eyelid Speculum (Group A)

Cotton-Tipped Applicator Retraction PROCEDURE

Two sterile cotton-tipped applicators are used to retract the eyelids (speculum-free) prior to intravitreal anti-VEGF injection (bevacizumab, aflibercept, or faricimab) using a Terumo 31G insulin syringe at the superotemporal quadrant. Applicators are removed immediately after needle withdrawal.

Cotton-Tipped Applicator (Group B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Jakkrit Juhong: lead

Related Publications (1)

• Chen HRQ, de Andrade GC, Arimori LK, et al. Comparison of intravitreal injection techniques with and without a speculum using eyelid retraction with a cotton-tipped applicator. Int J Retina Vitreous. 2025;11:119. doi:10.1186/s40942-025-00739-5

  BACKGROUND

MeSH Terms

Conditions

Retinal Vein Occlusion; Patient Satisfaction

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Jakkrit Juhong, MD

  Walailak University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jakkrit Juhong, MD

CONTACT

+66816773406; jakkrit.ju@wu.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor (nurse measuring VAS pain score and procedure time) is blinded to group allocation. Blinding of participants and the care provider (injecting surgeon) is not feasible due to the nature of the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 18, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share