Actively Recruiting
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
Eligibility Criteria
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)
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
Actively Recruiting
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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