OphthalmologyPhase 4NCT06874452
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
A Phase 4 study testing Alprazolam (Xanax) in people with Ophthalmology and Cataract Surgery Anesthesia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ophthalmology, Cataract Surgery Anesthesia, Oral Anxiolytic
- What is being tested?
- Alprazolam (Xanax)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Mar 2025to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years old.
- Enrolled in "Anxiety and surgery satisfaction for cataract patient with different state anxiety" (Research Ethics Committee Case No.: 202302067MINB).
- Plan to undergo phacoemulsification and intraocular lens implantation surgery with topical anesthetic on the second eye at the Department of Ophthalmology.
- Subject who does not have side effect from XANAX.
Who cannot join
- Presence of any surgery contraindications.
- Presence of any medication contraindications.
- 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.
- Regular use of anti-anxiety medications, sleeping pills, or analgesics before the procedure.
- Pregnancy or breastfeeding during the preoperative period.
- Severe corneal diseases, overripe cataracts, small pupils, or lens dislocation leading to difficulties in conventional surgery.
- Patients under surface anesthesia who cannot fully cooperate with the surgical procedure.
- Pregnant or uncertain pregnancy status (women under 55 years old to be verbally asked by research team members).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Chiun Ho Hou, Ph.D, +88623123456 ext. 262131, chiunhohou@gmail.com
About this study
Official title: Pain, Anxiety and Anesthetic Satisfaction for Patient With Different State Anxiety Underwent Cataract Surgery With Topical Anesthesia. 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.
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.
Read the detailed description
BACKGROUNDS Nowadays, phacoemulsification for cataract treatment is the most common surgical procedure performed and anesthetics procedure has been shifted from retrobulbar or peribulbar anesthesia to topical anesthesia (TA). Phacoemulsification under TA proved to be a safe and low risk procedure with the incidence of adverse events requiring medical emergency team interventions to be 0.04%. However, it is not uncommon that patients can suffer from pain, anxiety and unpleasant visual sensation during this procedure. Complementary sedation has long been thought to alleviate the anxiety and pain of the patient during surgery with local anesthesia. Studies revealed that approximately one fourth of the patients underwent phacoemulsification under TA or retrobulbar anesthesia requested additional intravenous sedation of midazolam. [8] However, the intravenous sedation, such as midazolam, propofol, or etomidate, increase the risk of additional anesthetic complications of heart rate, blood pressure, body temperature, and nausea, [9,10] and therefore, anesthesia monitoring was mandatory during the surgery.
Compared with intravenous sedation, oral sedation is less costly and less invasive. Studies with different oral sedation agents revealed different effects. In the study of 41 patients serving themselves as control, patients reported more pain and photophobia in the surgery with TA alone than the other with midazolam syrup and oral transmucosal fentanyl citrate. However, two studies comparing oral diazepam or triazolam with intravenous midazolam showed similar rates of anxiety and pain or noninferior satisfaction. Moreover, the randomized control trial containing 50 procedures in each groups revealed that patients received TA alone during phacoemulsification reported similar pain or anxiety level to those received complementary intravenous midazolam. Despite the abundant results from above, nearly 40% patients reported moderate to extremely anxiety during phacoemulsification under TA, and approximate 7% of patients rated themselves extreme anxiety or were diagnosed as anxiety. A simple comparison between with or without complementary sedation for general patients underwent phacoemulsification with TA is merely not enough. Further investigations to reduce the anxiety experienced during phacoemulsification with TA according to patients' characteristics is therefore mandatory. Previous studies had showed that patients with higher level of trait anxiety reported higher anxiety response for a stressful situation. Preoperative anxiety levels were also reported to be a significant predictor of pain experience during phacoemulsification with TA. The need for complementary sedation could be different in patients with different trait anxiety. Furthermore, different severity levels of anxiety and pain were experienced during the first and second eye surgery. Therefore, in this study, the investigators will investigate the trait anxiety of patients planned for phacoemulsification under TA and its effect on their anesthetic satisfaction with complementary oral sedation. The investigators will also analysis the anxiety and pain experienced in the first and second eye phacoemulsification in patients with different levels of trait anxiety. The investigators choose alprazolam as the oral sedative. It was reported to have a shorter half-life and less side effects of drowsiness and lightheadedness than diazepam used in previous studies.
- Being tested
- Alprazolam (Xanax), Placebo Tablets
- Keywords
- oral anti-anxiety drugs, oral anxiolytic, ophthalmology, cataract surgery anesthesia, satisfaction survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alprazolam (Xanax)Drug
The patients will each receive a single tablet of 0.5mg Alprazolam 30 minutes before surgery. Patients older than 65 years or with liver disease will receive a reduced dose of 0.25 mg rather than 0.5 mg of oral Alprazolam 30 minutes before surgery.
Placebo TabletsOther
The patients will each receive a single tablet of placebo 30 minutes before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Xanax | Experimental | 0.5mg XANAX or 0.25MG XANAX for patients older than 65 years or with liver disease. Receives: Drug: Alprazolam (Xanax) |
| placebo | Placebo comparator | The placebo tablet is visually identical to the experiment group. Receives: Other: Placebo Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthesia Satisfaction Assessment
The anesthesia satisfaction rating scale evaluates patients' satisfaction with the anesthesia experience during surgical procedures, focusing on factors such as pain management, comfort, and communication with the anesthesia team. The scales typically use a numerical rating system, such as a 10-point scale, where higher scores indicate greater satisfaction.
Measured: 1 day
Secondary outcomes (2)
The change of preoperative and postoperative anxiety level
The change of preoperative and postoperative anxiety level is evaluation with State-Trait Anxiety Inventory (STAI) and Beck Anxiety Inventory (BAI). STAI is focus on state anxiety (SA) and trait anxiety (TA). The inventory comprises 40 items, with 20 items assessing state anxiety and 20 items assessing trait anxiety. Each item is rated on a 4-point scale (1 to 4), resulting in a total score range of 20 to 80 for both SA and TA. Higher scores indicate more severe anxiety. BAI consists of 21 items covering physiological and cognitive anxiety symptoms, such as palpitations, breathlessness, and tension. Each item is rated on a 4-point scale (0 to 3) based on the frequency or severity of symptoms, with a total score range of 0 to 63. Higher scores indicate more severe anxiety.
Measured: 1 day
Level of postoperative pain
The immediate postoperative pain levels is documented to assess the patient's postoperative satisfaction. The pain level is rated on a 10-point scale (0 to 10). 0 point represents no pain, 1-2 points represent mild pain, 3-4 points represent moderate pain, 5-6 points represent severe pain, 7-8 points represent very severe pain, and 9-10 points represent worst possible pain.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start25 Mar 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OphthalmologyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- open label, double-arm study
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chiun Ho Hou, Ph.D, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874452
- Sponsor's protocol ID
- 202410134MINC
- Status last verified
- Apr 2026
- First submitted
- 4 Mar 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain, Anxiety and Anesthetic Satisfaction for Patient With Different State Anxiety Underwent Cataract Surgery With Topical Anesthesia. 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.
- ClinicalTrials.gov ID
- NCT06874452
- Acronym / sponsor ID
- 202410134MINC
- Keywords
- oral anti-anxiety drugs, oral anxiolytic, ophthalmology, cataract surgery anesthesia, satisfaction survey
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUNDS Nowadays, phacoemulsification for cataract treatment is the most common surgical procedure performed and anesthetics procedure has been shifted from retrobulbar or peribulbar anesthesia to topical anesthesia (TA). Phacoemulsification under TA proved to be a safe and low risk procedure with the incidence of adverse events requiring medical emergency team interventions to be 0.04%. However, it is not uncommon that patients can suffer from pain, anxiety and unpleasant visual sensation during this procedure. Complementary sedation has long been thought to alleviate the anxiety and pain of the patient during surgery with local anesthesia. Studies revealed that approximately one fourth of the patients underwent phacoemulsification under TA or retrobulbar anesthesia requested additional intravenous sedation of midazolam. [8] However, the intravenous sedation, such as midazolam, propofol, or etomidate, increase the risk of additional anesthetic complications of heart rate, blood pressure, body temperature, and nausea, [9,10] and therefore, anesthesia monitoring was mandatory during the surgery.
Compared with intravenous sedation, oral sedation is less costly and less invasive. Studies with different oral sedation agents revealed different effects. In the study of 41 patients serving themselves as control, patients reported more pain and photophobia in the surgery with TA alone than the other with midazolam syrup and oral transmucosal fentanyl citrate. However, two studies comparing oral diazepam or triazolam with intravenous midazolam showed similar rates of anxiety and pain or noninferior satisfaction. Moreover, the randomized control trial containing 50 procedures in each groups revealed that patients received TA alone during phacoemulsification reported similar pain or anxiety level to those received complementary intravenous midazolam. Despite the abundant results from above, nearly 40% patients reported moderate to extremely anxiety during phacoemulsification under TA, and approximate 7% of patients rated themselves extreme anxiety or were diagnosed as anxiety. A simple comparison between with or without complementary sedation for general patients underwent phacoemulsification with TA is merely not enough. Further investigations to reduce the anxiety experienced during phacoemulsification with TA according to patients' characteristics is therefore mandatory. Previous studies had showed that patients with higher level of trait anxiety reported higher anxiety response for a stressful situation. Preoperative anxiety levels were also reported to be a significant predictor of pain experience during phacoemulsification with TA. The need for complementary sedation could be different in patients with different trait anxiety. Furthermore, different severity levels of anxiety and pain were experienced during the first and second eye surgery. Therefore, in this study, the investigators will investigate the trait anxiety of patients planned for phacoemulsification under TA and its effect on their anesthetic satisfaction with complementary oral sedation. The investigators will also analysis the anxiety and pain experienced in the first and second eye phacoemulsification in patients with different levels of trait anxiety. The investigators choose alprazolam as the oral sedative. It was reported to have a shorter half-life and less side effects of drowsiness and lightheadedness than diazepam used in previous studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open label, double-arm study
| Arm | Type | Receives |
|---|---|---|
| Xanax | Experimental | Drug: Alprazolam (Xanax)0.5mg XANAX or 0.25MG XANAX for patients older than 65 years or with liver disease. |
| placebo | Placebo comparator | Other: Placebo TabletsThe placebo tablet is visually identical to the experiment group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 80 years old.
- Enrolled in "Anxiety and surgery satisfaction for cataract patient with different state anxiety" (Research Ethics Committee Case No.: 202302067MINB).
- Plan to undergo phacoemulsification and intraocular lens implantation surgery with topical anesthetic on the second eye at the Department of Ophthalmology.
- Subject who does not have side effect from XANAX.
Key exclusion criteria (8 listed)
- Presence of any surgery contraindications.
- Presence of any medication contraindications.
- 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.
- Regular use of anti-anxiety medications, sleeping pills, or analgesics before the procedure.
- Pregnancy or breastfeeding during the preoperative period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alprazolam (Xanax)The patients will each receive a single tablet of 0.5mg Alprazolam 30 minutes before surgery. Patients older than 65 years or with liver disease will receive a reduced dose of 0.25 mg rather than 0.5 mg of oral Alprazolam 30 minutes before surgery. | Drug | Xanax |
| Placebo TabletsThe patients will each receive a single tablet of placebo 30 minutes before surgery. | Other | placebo |
Primary outcome
Anesthesia Satisfaction Assessment
Time frame: 1 day
The anesthesia satisfaction rating scale evaluates patients' satisfaction with the anesthesia experience during surgical procedures, focusing on factors such as pain management, comfort, and communication with the anesthesia team. The scales typically use a numerical rating system, such as a 10-point scale, where higher scores indicate greater satisfaction.
2 secondary outcomes
The change of preoperative and postoperative anxiety level
Time frame: 1 day
Level of postoperative pain
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Ophthalmology
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
Not yet recruiting
Visual Symptom Simulator
Visual Disturbance
Not yet recruiting
AI-Assisted Systemic Health Risk Assessment in General Ophthalmology
Systemic Health Risk
Recruiting
Robotic RVO Trial: Robot-assisted Retinal Vein Cannulation in Patients With Retinal Vein Occlusions
Retinal Vein Occlusion (RVO)
RecruitingObservational study
Nanopore Sequencing in Ophthalmology
Endophthalmitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chiun Ho Hou, Ph.D principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alprazolam (Xanax) in people with Ophthalmology and Cataract Surgery Anesthesia, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiun Ho Hou, Ph.D (+88623123456 ext. 262131, chiunhohou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anesthesia Satisfaction Assessment (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.