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

Study acronym: IVI-RETRACT
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated September 25, 2026 (before its estimated October 7, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Trial status changed: Not Yet Recruiting → Active, Not Recruiting Show 8 more changesShow less
    • Primary completion moved earlier from Jun 2027 to Oct 7, 2026
    • Study completion moved earlier from Aug 2027 to Oct 7, 2026
    • Start date changed from estimate of Oct 2026 to Sep 9, 2026
    • Enrollment target: estimated 120 to confirmed 129
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 9 words
    • Study description expanded, about 233 words
    • Publications: details revised at 1 of 1 entry
  2. Notable Start date: Jun 2026 to Oct 2026
    • Study title shortened, about 4 words
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07481500
Lead Sponsor Jakkrit Juhong
Conditions
(from sponsor)
Neovascular Age-Related Macular Degeneration (nAMD), Diabetic Macular Edema, Retinal Vein Occlusion, Intravitreal Injections, Polypoidal Choroidal Vasculopathy
Related terms Patient Satisfaction, Polypoidal Choroidal Vasculopathy, Retinal Vein Occlusion
Enrollment 129 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov