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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Procedural Video Viewing on Patients Undergoing Intravitreal Anti-VEGF Injections
- ClinicalTrials.gov ID
- NCT07002372
- Acronym / sponsor ID
- 2024-1393
- Conditions
- Age Related Macular Degeneration, Diabetic Retinopathy, Choroidal Neovascularization, Retinal Vein Occlusion, Cystoid Macular Edema
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 5 Aug 2025 (estimated)
- Study completion
- 5 Oct 2025 (estimated)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Procedural video viewing Group | Experimental | Behavioral: Procedure video viewingParticipants will watch an educational video explaining the injection procedure prior to treatment. |
| Control Group | No intervention | –Participants will not view the video before the treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Procedure video viewingPatients who have never had an intravitreal injection before will be randomly assigned to watch an educational video about the procedure prior to treatment. | Behavioural | Procedural video viewing Group |
Primary outcome
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.
1 secondary outcome
Anxiety levels assessed by State-Trait Anxiety Inventory-State (STAI-S)
Time frame: 30 minutes before and after the procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Background: PubMed 31305506Yahalomi 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.
- Background: PubMed 28064517Boyle 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.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoyun Fang, MD., PhD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyun Fang, MD., PhD. (+ 86 13588411946, xiaoyunfang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate and area of subconjunctival hemorrhage (time frame: 3 minutes after the intravitreal injection procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07002372, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.