An interventional study of Procedure video viewing in Age Related Macular Degeneration, Diabetic Retinopathy and Choroidal Neovascularization, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-03.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Other
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
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.
756 studies on the registry are indexed under Macular Edema; 65 are open to participants now.
This study's planned enrollment of 182 is above the median of 56 across 584 interventional studies indexed under Macular Edema.
Browse Macular Edema studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.
Compared within Macular Edema, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Macular Degeneration. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will watch an educational video explaining the injection procedure prior to treatment.
Behavioral: Procedure video viewing
Participants will not view the video before the treatment.
Patients who have never had an intravitreal injection before will be randomly assigned to watch an educational video about the procedure prior to treatment.
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.
Time frame: 3 minutes after the intravitreal injection procedure.
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
Time frame: 30 minutes before and after the procedure.
Patient satisfaction assessed by a satisfaction score questionnaire
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".
Time frame: 30 minutes after the procedure.
Physician's assessment of patient cooperation during the 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.
Time frame: Immediately after the intravitreal injection procedure
Total procedure time
The time duration from the start of disinfection to the completion of the injection.
Time frame: During the procedure.
Plan to share: Yes — Only IPD used in the results publication.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Second Affiliated Hospital, School of Medicine, Zhejiang University →