Actively Recruiting

Phase 4
Age: 18Years - 80Years
All Genders
ID06874452

Pain, Anxiety and Anesthetic Satisfaction for Patients Undergoing Cataract Surgery With Topical Anesthesia Using Oral Anti-Anxiety Drug Alprazolam Compared to Placebo

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

250

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Phacoemulsification is a common cataract surgery performed under topical anesthesia, which is generally safe but can cause pain, anxiety, and discomfort for some patients. This research evaluates the effect of oral anti-anxiety medication, specifically Alprazolam, on improving patient satisfaction during second eye cataract surgery. The study aims to clarify whether oral sedation can reduce pain, anxiety, and side effects like nausea and dizziness compared to no sedation during phacoemulsification. Patients will receive either a single oral dose of Alprazolam or a placebo tablet 30 minutes before surgery. The dose of Alprazolam is 0.5 mg for most patients, with a reduced 0.25 mg dose for those over 65 years or with liver disease. The study compares these groups to assess how oral sedation affects anxiety, pain, and surgical satisfaction. This is an extension study involving patients undergoing surgery on their second eye with topical anesthesia. During the trial, participants will complete questionnaires assessing pain, anxiety, and overall satisfaction before and after surgery. Researchers will monitor intraoperative discomfort and postoperative anxiety levels. Data from approximately 250 patients will be collected and analyzed for these outcomes. This study runs from March 2025 to December 2027, focusing on improving cataract surgery experiences safely and conveniently.

CONDITIONS

Brief 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 "Anxiety and surgery satisfaction for cataract patient with different state anxiety" study
  • Planning to undergo second eye phacoemulsification and intraocular lens implantation with topical anesthesia
  • No history of side effects from Alprazolam (Xanax)
Not Eligible

You will not qualify if you...

  • Any contraindications to surgery
  • Any contraindications to medications
  • Unable to provide clear and complete answers to questionnaires or no preoperative anxiety or low anxiety scores
  • Regular use of anti-anxiety drugs, sleeping pills, or painkillers
  • Pregnancy or breastfeeding during the preoperative period
  • Severe corneal diseases, advanced cataracts, small pupils, or lens dislocation complicating surgery
  • Inability to cooperate with surgery under topical anesthesia
  • Pregnant or uncertain pregnancy status, especially in women under 55 years old

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day of surgery

Participants receive a single dose of oral Alprazolam or a placebo 30 minutes before their second eye cataract surgery under topical anesthesia.

1 surgery visit (in-person)

Follow-up

Duration - 1 day

Participants complete assessments of anesthesia satisfaction, anxiety, and pain after surgery.

1 post-surgery visit (in-person or remote)

Trial Site Locations

Total: 1 location

1

National Taiwan University Hospital

Taipei, Taiwan, 100

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Research Team

C

Chiun Ho Hou, Ph.D

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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