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

NCT07481500 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-03-18

No results posted yet for this study

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

Interventions

PROCEDURE

Eyelid Speculum Retraction

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.

PROCEDURE

Cotton-Tipped Applicator Retraction

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.

Sponsors & Collaborators

  • Jakkrit Juhong

    lead OTHER

Principal Investigators

  • Jakkrit Juhong, MD · Walailak University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-06-30
Completion
2027-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07481500 on ClinicalTrials.gov