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

RECRUITINGPhase 4Sponsored by National Taiwan University Hospital
Actively Recruiting
PhasePhase 4
SponsorNational Taiwan University Hospital
Started2025-03-25
Est. completion2027-12-31
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted

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 (XANAX) on cataract surgery has not been intensively studied. Therefore, the purpose of this study is to investigate the impact of XANAX 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

Age: 18 Years – 80 YearsHealthy volunteers accepted
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).

Conditions5

AnxietyCataract Surgery AnesthesiaOphthalmologyOral AnxiolyticSatisfaction Survey

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