VR for Cataract Anxiety Lowering Management--A RCT Study (VR-CALM)

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: VR-based Informed Consent; Cataract and IOL Surgery

Treatments: Device: Virtual reality simulation of intraoperative audiovisual experience

Study type: Interventional

Funder types: Other

Identifiers

NCT07620821

2026KS258 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 260 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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260 participants in 2 patient groups

VR Intervention Group

Experimental group

Description:

30 participants receive virtual reality simulation of intraoperative audiovisual experience before the surgery.

Treatment:

Device: Virtual reality simulation of intraoperative audiovisual experience

Usual Care Group (No VR)

No Intervention group

Description:

Participants with conventional preoperative instructions (no VR video)