Cataract and IOL Surgery, VR-based Informed Consent
Conditions
Brief summary
Cataract is currently the leading cause of blindness globally, and surgery is the only effective treatment. With the advancement of medical technology, cataract surgery is usually performed under topical anesthesia, which means patients will be awake during the procedure, able to see the light from the surgical lamp and hear the sounds of surgical instruments being operated. Some patients may feel nervous or scared due to unfamiliarity with the surgical process, which may lead to increased blood pressure, rapid heartbeat, and even affect their cooperation during the surgery.Virtual reality (VR) technology is a new multimedia technology. By wearing VR glasses, patients can immerse themselves in a virtual world and see and hear realistic scenes. Through this study, the investigators aim to investigate whether allowing cataract patients to "experience" a surgical procedure in advance through VR glasses before cataract surgery can help alleviate their nervousness during the actual surgery.
Interventions
This Virtual reality video simulates the audiovisual experience of phacoemulsification (Phaco and IOL) surgery
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with cataracts in one or both eyes, and planning to undergo surgical treatment 2. Voluntarily participate in this trial and sign the informed consent form.
Exclusion criteria
1. History of previous ophthalmic surgery 2. Suffering from severe hearing impairment, unable to comprehend VR video content. 3. Those who suffer from cognitive dysfunction or mental illness and are unable to cooperate in completing the scale assessment. 4. Suffering from severe macular diseases, glaucoma, or other ocular diseases that may affect surgery or interfere with the assessment of tension level. 5. Assessed as intolerant to topical anesthesia for the surgery. 6. History of motion sickness, severe vertigo, or intolerance to VR video viewing (such as claustrophobia). 7. Other situations where the researcher deems the participant unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of anxiety level evaluated by numerical rating scale (NRS) | collected before the intervention (VR video or conventional preoperative instructions) , immediately before the surgery, and immediately after the surgery | The change of participants self-reported anxiety levels before and during the surgery, evaluated by numerical rating scale (NRS), from 0 (no anxiety) to 10 (highest anxiety) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of Heart Rate | Before the intervention (VR video or conventional preoperative instructions) , immediately before the surgery, and during phacoemulsification. | The change of heart rates before and during the surgery |
| The change of blood pressure | collected before the intervention (VR video or conventional preoperative instructions) , immediately before the surgery, and during phacoemulsification | The change of blood pressure before and during the surgery |
| Pain level | collected immediately after the surgery | Intraoperative participants self-reported pain level using numerical rating scale (NRS), from 0 (no pain) to 10 (highest pain) |
| Patients' cooperation level | collected immediately after the surgery | The numerical rating scale (NRS) score of patient cooperation level assessed by the surgeon, from 0 (very bad cooperation) to 5 (very good cooperation) |
Countries
China
Outcome results
None listed