Clinical Outcomes of Sedation in Cataract Surgery Performed Under Topical Anesthesia (NCT07347886) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Outcomes of Sedation in Cataract Surgery Performed Under Topical Anesthesia
Turkey (Türkiye)120 participantsStarted 2026-01
Plain-language summary
This study aims to evaluate the clinical outcomes of different sedation strategies in patients undergoing cataract surgery performed under topical anesthesia. Cataract surgery is commonly performed under topical anesthesia; however, some patients may experience anxiety, discomfort, or inadequate cooperation during the procedure. Sedation may improve patient comfort and surgical conditions, but it may also be associated with potential adverse effects.
In this randomized, prospective study, patients will be assigned to one of three groups: topical anesthesia alone, topical anesthesia combined with midazolam, or topical anesthesia combined with midazolam and fentanyl. Intraoperative sedation levels, hemodynamic parameters, patient satisfaction, and surgeon satisfaction will be assessed and compared among the groups.
The results of this study are expected to provide evidence regarding the effectiveness and safety of sedation during cataract surgery performed under topical anesthesia and to help optimize perioperative sedation strategies for these patients.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 50 years
* American Society of Anesthesiologists (ASA) physical status I-III
* Patients scheduled for elective unilateral cataract surgery
* Surgery planned to be performed under topical anesthesia
* Ability to understand the study procedures and provide written informed consent after being fully informed about the study
Exclusion Criteria:
* Refusal to participate in the study or withdrawal of consent at any stage of the study
* Known intolerance or contraindication to sedative and/or opioid medications
* Presence of significant cardiac arrhythmias
* Severe chronic obstructive pulmonary disease (COPD)
* Hepatic or renal failure
* Inability to cooperate due to cognitive impairment or hearing disability
* Opioid dependence
* Diagnosis of obstructive sleep apnea syndrome (OSAS)
* New York Heart Association (NYHA) class III-IV heart failure
* Conversion to general anesthesia for any reason during surgery
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.