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
| NCT ID | NCT06874452 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | National Taiwan University Hospital |
| Condition | Ophthalmology |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-03-25 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 250 participants in total. It began in 2025-03-25 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Age between 18 and 80 years old. 2. Enrolled in "Anxiety and surgery satisfaction for cataract patient with different state anxiety" (Research Ethics Committee Case No.: 202302067MINB). 3. Plan to undergo phacoemulsification and intraocular lens implantation surgery with topical anesthetic on the second eye at the Department of Ophthalmology. 4. Subject who does not have side effect from XANAX. Exclusion Criteria: 1. Presence of any surgery contraindications. 2. Presence of any medication contraindications. 3. Inability to provide clear and complete answers to relevant questionnaires, or expression of no preoperative anxiety during the outpatient visit, or scores below 21 on the STAI-S or STAI-T assessment. 4. Regular use of anti-anxiety medications, sleeping pills, or analgesics before the procedure. 5. Pregnancy or breastfeeding during the preoperative period. 6. Severe corneal diseases, overripe cataracts, small pupils, or lens dislocation leading to difficulties in conventional surgery. 7. Patients under surface anesthesia who cannot fully cooperate with the surgical procedure. 8. Pregnant or uncertain pregnancy status (women under 55 years old to be verbally asked by research team members).
Contact & Investigator
Chiun Ho Hou, Ph.D
PRINCIPAL INVESTIGATOR
National Taiwan University Hospital
Frequently Asked Questions
Who can join the NCT06874452 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Ophthalmology. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06874452 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06874452 currently recruiting?
Yes, NCT06874452 is actively recruiting participants. Contact the research team at chiunhohou@gmail.com for enrollment information.
Where is the NCT06874452 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT06874452 clinical trial?
NCT06874452 is sponsored by National Taiwan University Hospital. The principal investigator is Chiun Ho Hou, Ph.D at National Taiwan University Hospital. The trial plans to enroll 250 participants.