Age Related Macular DegenerationNCT07002372
Effect of Video Viewing on Intravitreal Injection Experience
A study testing Procedure video viewing in people with Age Related Macular Degeneration and Diabetic Retinopathy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age Related Macular Degeneration, Diabetic Retinopathy, Choroidal Neovascularization
- What is being tested?
- Procedure video viewing
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2025to 5 Oct 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Fang Zheng, 18258499106, zhengfanggo@zju.edu.cn
About this study
Official title: Impact of Procedural Video Viewing on Patients Undergoing Intravitreal Anti-VEGF Injections
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
Read more
- Can viewing the procedural video prior to treatment reduce the rate and/or area of subconjunctival hemorrhage?
- 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.
- Conditions
- Age Related Macular Degeneration, Diabetic Retinopathy, Choroidal Neovascularization, Retinal Vein Occlusion, Cystoid Macular Edema
- Being tested
- Procedure video viewing
- Medical subject headings
- Macular Degeneration, Diabetic Retinopathy, Choroidal Neovascularization, Retinal Vein Occlusion, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure video viewingBehavioural
Patients who have never had an intravitreal injection before will be randomly assigned to watch an educational video about the procedure prior to treatment.
| Study group | Role | What they receive |
|---|---|---|
| Procedural video viewing Group | Experimental | Participants will watch an educational video explaining the injection procedure prior to treatment. Receives: Behavioral: Procedure video viewing |
| Control Group | No intervention | Participants will not view the video before the treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 minutes after the intravitreal injection procedure.
Secondary outcomes (1)
Anxiety levels assessed by State-Trait Anxiety Inventory-State (STAI-S)
State-Trait Anxiety Inventory-State (STAI-S) questionnaire both before and after treatment to assess changes in anxiety levels
Measured: 30 minutes before and after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start5 May 2025
- Primary completion5 Aug 2025 (estimated)
- Study completion5 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoyun Fang, MD., PhD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002372
- Sponsor's protocol ID
- 2024-1393
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication.
Publications
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.
PubMed 31305506Boyle 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.
PubMed 28064517