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Completed

NCT Number: NCT07620821

VR for Cataract Anxiety Lowering Management--A RCT Study

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.

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Key information

Conditions

Cataract and IOL Surgery Cataract Eye Diseases Lens Diseases VR-based Informed Consent

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Virtual reality simulation of intraoperative audiovisual experience

Device

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

Other names: VR simulation, VR video

Primary outcomes

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

    Time frame: 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 outcomes

  1. The change of Heart Rate

    Time frame: 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

  2. The change of blood pressure

    Time frame: 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

  3. Pain level

    Time frame: collected immediately after the surgery

    Intraoperative participants self-reported pain level using numerical rating scale (NRS), from 0 (no pain) to 10 (highest pain)

  4. Patients' cooperation level

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

A Randomized Controlled Study of Virtual Reality Simulation of Intraoperative Audiovisual Experience to Reduce Anxiety in Cataract Surgery Patients

Acronym: VR-CALM

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 2, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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