Actively Recruiting

Phase 4
Age: 18Years - 80Years
All Genders
NCT06874452

An Extension Test of Whether to Use Oral Anti-anxiety Drugs (Alprazolam) When Patients Choose Second Eye Cataract Surgery After Unblinding, and Analyze Their Anxiety, Satisfaction and Pain Satisfaction

Led by National Taiwan University Hospital · Updated on 2026-04-24

250

Participants Needed

1

Research Sites

144 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Phacoemulsification is one of the most used surgical methods for cataract surgery today, and the surgeries are under the anesthetic and sedative to make it comfortable and safe for patients. The most important issue is which method is the best for reducing the patient's anxiety, pain, and discomfort during surgery. Previous studies have analyzed the impact of intravenous injection of sedative on the quality of phacoemulsification surgery; however, the impact of oral anti-anxiety drugs (Alprazolam) on cataract surgery has not been intensively studied. Therefore, the purpose of this study is to investigate the impact of Alprazolam on satisfaction in cataract surgery. Oral sedation is more convenient and safer than intravenous sedation. Therefore, the investigators will further analyze whether patients using oral anti-anxiety drugs will have an improvement in the pain, anxiety, overall satisfaction, and side effects related to nausea and dizziness in the phacoemulsification surgery. This study will detailed record the patient's status in various aspects using questionnaire scales and scores. Through this research, the investigators will have the opportunity to comprehensively improve the surgical quality of cataract patients in a safe and convenient manner. The investigators plan to collect data from patients who participated in the study "Anxiety and surgery satisfaction for cataract patient with different state anxiety" (Research Ethics Committee Case No.: 202302067MINB) from October 2023 to August 2025, and plan to undergo phacoemulsification and intraocular lens implantation surgery in their second eye with local anesthetic at the Department of Ophthalmology, National Taiwan University Hospital. The sample size of 250 participants was determined based on the type of intervention, expected effect size, outcome variability, desired statistical significance, trial power, and experiences from similar studies. Vulnerable populations and those with any relevant contraindications will be excluded during the enrollment process. All medical records and surgical process data, including privacy-related information, will only be accessible to professional medical personnel for analysis. The focus of this study will be on intraoperative satisfaction, pain scores, relevant discomfort symptoms during the surgery, and postoperative anxiety assessment scales.

CONDITIONS

Official Title

An Extension Test of Whether to Use Oral Anti-anxiety Drugs (Alprazolam) When Patients Choose Second Eye Cataract Surgery After Unblinding, and Analyze Their Anxiety, Satisfaction and Pain Satisfaction

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years old
  • Enrolled in the related anxiety and surgery satisfaction study (Research Ethics Committee Case No.: 202302067MINB)
  • Planning to undergo phacoemulsification and intraocular lens implantation with topical anesthesia on the second eye
  • No history of side effects from Alprazolam (Xanax)
Not Eligible

You will not qualify if you...

  • Any contraindication to surgery
  • Any contraindication to medication
  • Unable to provide clear and complete answers to questionnaires
  • No preoperative anxiety or STAI-S/STAI-T scores below 21
  • Regular use of anti-anxiety drugs, sleeping pills, or painkillers before surgery
  • Pregnant or breastfeeding during the preoperative period
  • Severe corneal diseases, advanced cataracts, small pupils, or lens dislocation preventing normal surgery
  • Inability to cooperate fully during surgery under surface anesthesia
  • Pregnant or uncertain pregnancy status (women under 55 years to be verbally asked)

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Taiwan University Hospital

Taipei, Taiwan, 100

Actively Recruiting

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Research Team

C

Chiun Ho Hou, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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