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NCT Number: NCT07002372

Effect of Video Viewing on Intravitreal Injection Experience

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.

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Key information

Conditions

Age Related Macular Degeneration CYSTOID MACULAR EDEMA Cardiovascular Diseases Choroid Diseases Choroidal Neovascularization Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Embolism and Thrombosis Endocrine System Diseases Eye Diseases Macular Degeneration Macular Edema Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Retinal Vein Occlusion Thrombosis Uveal Diseases Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location status: Recruiting

Location contact

Fang Zheng

CONTACT

[email protected]

18258499106

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Procedure video viewing

Behavioral

Patients who have never had an intravitreal injection before will be randomly assigned to watch an educational video about the procedure prior to treatment.

Primary outcomes

  1. Rate and area of subconjunctival hemorrhage

    Time frame: 3 minutes after the intravitreal injection procedure.

    After the injection, a photograph of the eye will be taken to document the presence of subconjunctival hemorrhage and to measure the hemorrhage area using ImageJ software.

Secondary outcomes

  1. Anxiety levels assessed by State-Trait Anxiety Inventory-State (STAI-S)

    Time frame: 30 minutes before and after the procedure.

    State-Trait Anxiety Inventory-State (STAI-S) questionnaire both before and after treatment to assess changes in anxiety levels

Other outcomes

  1. Patient satisfaction assessed by a satisfaction score questionnaire

    Time frame: 30 minutes after the procedure.

    Patient satisfaction with the treatment process will be assessed using a 10-point Likert scale satisfaction score collected after the procedure, where 1 indicates "not satisfied at all" and 10 indicates "completely satisfied".

  2. Physician's assessment of patient cooperation during the procedure

    Time frame: Immediately after the intravitreal injection procedure

    Physician's assessment of patient cooperation during the procedure Patient cooperation will be assessed by the physician immediately after the procedure using a 10-point Likert scale, where 1 indicates completely uncooperative and 10 indicates fully cooperative. The scale is based on observable patient behavior such as adherence to instructions, physical movements, and verbal interaction during the procedure.

  3. Total procedure time

    Time frame: During the procedure.

    The time duration from the start of disinfection to the completion of the injection.

Study contacts

Contact information is provided by the study sponsor or research team.

Fang Zheng, MD., PhD

CONTACT

[email protected]

+86 18258499106

Xiaoyun Fang, MD., PhD.

CONTACT

[email protected]

+ 86 13588411946

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Impact of Procedural Video Viewing on Patients Undergoing Intravitreal Anti-VEGF Injections

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 3, 2025
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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