VR for Cataract Anxiety Lowering Management--A RCT Study

NCT07620821 | Not Yet Recruiting

• 1 other identifier: 2026KS258
• Study Type: interventional
• Target: 260
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cataract and IOL Surgery; VR-based Informed Consent

Outcome Measures

Primary Outcomes (1)

• The change of anxiety level evaluated by numerical rating scale (NRS)

  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)

  collected before the intervention (VR video or conventional preoperative instructions) , immediately before the surgery, and immediately after the surgery

Secondary Outcomes (4)

• The change of Heart Rate

  Before the intervention (VR video or conventional preoperative instructions) , immediately before the surgery, and during phacoemulsification.

• The change of blood pressure

  collected before the intervention (VR video or conventional preoperative instructions) , immediately before the surgery, and during phacoemulsification

• Pain level

  collected immediately after the surgery

• Patients' cooperation level

  collected immediately after the surgery

Study Arms (2)

VR Intervention Group

EXPERIMENTAL

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

Device: Virtual reality simulation of intraoperative audiovisual experience

Usual Care Group (No VR)

NO INTERVENTION

Participants with conventional preoperative instructions (no VR video)

Interventions

Virtual reality simulation of intraoperative audiovisual experience DEVICE

This Virtual reality video simulates the audiovisual experience of phacoemulsification (Phaco and IOL) surgery

Also known as: VR simulation, VR video

VR Intervention Group

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with cataracts in one or both eyes, and planning to undergo surgical treatment
• Voluntarily participate in this trial and sign the informed consent form.

You may not qualify if:

• History of previous ophthalmic surgery
• Suffering from severe hearing impairment, unable to comprehend VR video content.
• Those who suffer from cognitive dysfunction or mental illness and are unable to cooperate in completing the scale assessment.
• Suffering from severe macular diseases, glaucoma, or other ocular diseases that may affect surgery or interfere with the assessment of tension level.
• Assessed as intolerant to topical anesthesia for the surgery.
• History of motion sickness, severe vertigo, or intolerance to VR video viewing (such as claustrophobia).
• Other situations where the researcher deems the participant unsuitable for participation in this study.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Central Study Contacts

Peiyao Jin

CONTACT

+8613564534911; peiyaojin@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share