Effect of Video Viewing on Intravitreal Injection Experience

NCT07002372 | Recruiting

• 1 other identifier: 2024-1393
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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

Conditions

Age Related Macular Degeneration; Diabetic Retinopathy; Choroidal Neovascularization; Retinal Vein Occlusion; Cystoid Macular Edema

Outcome Measures

Primary Outcomes (1)

• Rate and area of subconjunctival hemorrhage

  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.

  3 minutes after the intravitreal injection procedure.

Secondary Outcomes (1)

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

  30 minutes before and after the procedure.

Other Outcomes (3)

• Patient satisfaction assessed by a satisfaction score questionnaire

  30 minutes after the procedure.

• Physician's assessment of patient cooperation during the procedure

  Immediately after the intravitreal injection procedure

• Total procedure time

  During the procedure.

Study Arms (2)

Procedural video viewing Group

EXPERIMENTAL

Participants will watch an educational video explaining the injection procedure prior to treatment.

Behavioral: Procedure video viewing

Control Group

NO INTERVENTION

Participants will not view the video before the treatment.

Interventions

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.

Procedural video viewing Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 31305506 BACKGROUND

• 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.

  PMID: 28064517 BACKGROUND

MeSH Terms

Conditions

Macular Degeneration; Diabetic Retinopathy; Choroidal Neovascularization; Retinal Vein Occlusion; Macular Edema

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Venous Thrombosis; Thrombosis; Embolism and Thrombosis

Study Officials

• Xiaoyun Fang, MD., PhD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoyun Fang, MD., PhD.

CONTACT

+ 86 13588411946; xiaoyunfang@zju.edu.cn

Fang Zheng, MD., PhD

CONTACT

+86 18258499106; zhengfanggo@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 3, 2025
• Study Start: May 5, 2025
• Primary Completion: August 5, 2025
• Study Completion: October 5, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CN (1)