Clinical trial NCT07002372: Effect of Video Viewing on Intravitreal Injection Experience
Official title: Impact of Procedural Video Viewing on Patients Undergoing Intravitreal Anti-VEGF Injections
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Age Related Macular Degeneration
Diabetic Retinopathy
Choroidal Neovascularization
Retinal Vein Occlusion
Cystoid Macular Edema
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Study Objective The goal of this clinical trial is to evaluate whether viewing a procedural video can improve the patient experience and reduce the incidence and severity of subconjunctival hemorrhage in individuals undergoing intravitreal anti-VEGF injections.

Key Research Questions

1. Can viewing the procedural video prior to treatment reduce the rate and/or area of subconjunctival hemorrhage?
2. Can the video improve the patient experience, specifically by reducing anxiety levels and increasing satisfaction with the treatment process?

Study Design Participants will be randomly assigned to either an intervention group, who will watch an educational video explaining the injection procedure, or a control group, who will not view the video.

All participants will complete the State-Trait Anxiety Inventory-State (STAI-S) questionnaire both before and after treatment to assess changes in anxiety levels.


Eligibility criteria: Inclusion Criteria:

* Patients who are receiving their first intravitreal injection of anti-VEGF medication due to retinal diseases
* Mentally competent, and able to communicate without barriers
* Willing to voluntarily sign an informed consent form.

Exclusion Criteria:

* History of previous eye surgery
* Best-corrected visual acuity in the better eye worse than 0.3
* The target eye is complicated with neovascular glaucoma.

Primary outcomes:
measure: Rate and area of subconjunctival hemorrhage
timeFrame: 3 minutes after the intravitreal injection procedure.
Secondary outcomes:
measure: Anxiety levels assessed by State-Trait Anxiety Inventory-State (STAI-S)
timeFrame: 30 minutes before and after the procedure.
Other outcomes:
measure: Patient satisfaction assessed by a satisfaction score questionnaire
timeFrame: 30 minutes after the procedure.
measure: Physician's assessment of patient cooperation during the procedure
timeFrame: Immediately after the intravitreal injection procedure
measure: Total procedure time
timeFrame: During the procedure.
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: 浙江省
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Xiaoyun Fang, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yahalomi T, Hecht I, Lagstein O, Nemet A, Pe'er L, Hadad F, Keren-Yaar A, Kassem R, Burgansky-Eliash Z, Bar A, Achiron A. REDUCTION OF POSTINTRAVITREAL INJECTION PAIN USING ICE: An Open-Label Interventional Randomized Controlled Trial. Retina. 2020 Jul;40(7):1434-1438. doi: 10.1097/IAE.0000000000002608.
citation: Boyle J, Vukicevic M, Koklanis K, Itsiopoulos C, Rees G. Experiences of patients undergoing repeated intravitreal anti-vascular endothelial growth factor injections for neovascular age-related macular degeneration. Psychol Health Med. 2018 Feb;23(2):127-140. doi: 10.1080/13548506.2016.1274040. Epub 2017 Jan 9.