Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-02 @ 9:01 AM
Study NCT ID:
NCT06506669
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-17
First Post:
2024-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cataract Monitored Anesthesia Care (MAC) Feasibility Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patients, clinicians (operating room nurses, ophthalmologists, and anesthesia staff), and research staff responsible for data collection and analysis will be blinded to the treatment group in order to minimize bias and maximize the validity of results.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A single-center, randomized, double-blinded, randomized pilot clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-14', 'studyFirstSubmitDate': '2024-06-25', 'studyFirstSubmitQcDate': '2024-07-11', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Satisfaction as assessed by the Iowa Satisfaction With Anesthesia Scale (ISAS)', 'timeFrame': '30 minutes, 1 day and 7 days after surgery', 'description': "The ISAS is a validated 11-question survey to find out how people feel about the sedation (i.e., monitored anesthesia care) they received during surgery that doesn't require general anesthesia. It asks about pain and overall feelings about the anesthesia care received. We will compare ISAS scores between patients who received oral sedation and patients who received placebo."}], 'secondaryOutcomes': [{'measure': 'Proportion of patients meeting eligibility criteria', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Number of patients meeting eligibility criteria divided by the total number of patients screened'}, {'measure': 'Proportion of patients completing all study surveys after cataract surgery', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Number of patients completing all study surveys after cataract surgery divided by the number of patients enrolled in the study'}, {'measure': 'Proportion of study patients who completed all required study procedures', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'The number of study patients who completed all required study procedures (before and after surgery) divided by the number of patients enrolled in the study.'}, {'measure': 'Incidence of sedation-related complications after surgery', 'timeFrame': '30 days after surgery', 'description': 'The number of patients with a sedation-related complication divided by the number of patients enrolled in the study.'}, {'measure': 'Quality of recovery after surgery using the Postoperative Quality of Recovery Scale (PQRS)', 'timeFrame': '30 minutes, 1 day and 7 days after surgery', 'description': 'The PQRS is a 6-question survey that assesses the quality of recovery of patients after surgery. It evaluates multiple aspects of recovery, including physiological, pain, emotional, brain function, and activities of daily living domains.'}, {'measure': 'Quality of recovery after surgery as measured by the Quality-of-Recovery-15 Questionnaire (QoR-15)', 'timeFrame': '1 day and 7 days after surgery', 'description': 'The QoR-15 is a survey that has 15 questions and is used to see how patients feel after surgery and helps to understand the trajectory of recovery from surgery and anesthesia. The survey includes questions about mood, including if patients are feeling anxious or depressed.'}, {'measure': 'Quality of recovery after surgery as measured by the Functional Recovery index (FRI)', 'timeFrame': '1 day and 7 days after surgery', 'description': 'The FRI is a 14-question survey to check how well patients can do normal activities after surgery. It asks about things like pain, moving around, and daily activities.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cataract surgery', 'oral sedation', 'intravenous sedation', 'conscious sedation', 'monitored anesthesia care', 'quality of recovery'], 'conditions': ['Cataract', 'Bilateral Senile Cataract', 'Anesthesia', 'Patient Satisfaction']}, 'referencesModule': {'references': [{'pmid': '25875258', 'type': 'BACKGROUND', 'citation': 'Chen CL, Lin GA, Bardach NS, Clay TH, Boscardin WJ, Gelb AW, Maze M, Gropper MA, Dudley RA. Preoperative medical testing in Medicare patients undergoing cataract surgery. N Engl J Med. 2015 Apr 16;372(16):1530-8. doi: 10.1056/NEJMsa1410846.'}, {'pmid': '29346472', 'type': 'BACKGROUND', 'citation': 'Chen CL, Clay TH, McLeod S, Chang HP, Gelb AW, Dudley RA. A Revised Estimate of Costs Associated With Routine Preoperative Testing in Medicare Cataract Patients With a Procedure-Specific Indicator. JAMA Ophthalmol. 2018 Mar 1;136(3):231-238. doi: 10.1001/jamaophthalmol.2017.6372.'}, {'pmid': '28242111', 'type': 'BACKGROUND', 'citation': 'Liu YC, Wilkins M, Kim T, Malyugin B, Mehta JS. Cataracts. Lancet. 2017 Aug 5;390(10094):600-612. doi: 10.1016/S0140-6736(17)30544-5. Epub 2017 Feb 25.'}, {'type': 'BACKGROUND', 'citation': 'Norregaard, J. C. Results from the International Cataract Surgery Outcomes Study. Acta Ophthalmologica Scandinavica 85, 5-32, doi:10.1111/j.1600-0420.2007.00937.x (2007).'}, {'type': 'BACKGROUND', 'citation': 'Kent, C. Cataract Surgery: Is an anesthesiologist necessary?, <https://www.reviewofophthalmology.com/article/cataract-surgery-is-an-anesthesiologist-necessary> (2009).'}, {'type': 'BACKGROUND', 'citation': 'Andrews, M. Anthem Calls On Eye Surgeons To Monitor Anesthesia During Cataract Surgery, <https://khn.org/news/anthem-calls-on-eye-surgeons-to-monitor-anesthesia-during-cataract-surgery/> (2018).'}, {'pmid': '26804760', 'type': 'BACKGROUND', 'citation': 'Ianchulev T, Litoff D, Ellinger D, Stiverson K, Packer M. Office-Based Cataract Surgery: Population Health Outcomes Study of More than 21 000 Cases in the United States. Ophthalmology. 2016 Apr;123(4):723-8. doi: 10.1016/j.ophtha.2015.12.020. Epub 2016 Jan 22.'}, {'pmid': '15691563', 'type': 'BACKGROUND', 'citation': 'Zakrzewski PA, Friel T, Fox G, Braga-Mele R. Monitored anesthesia care provided by registered respiratory care practitioners during cataract surgery: a report of 1957 cases. Ophthalmology. 2005 Feb;112(2):272-7. doi: 10.1016/j.ophtha.2004.08.016.'}, {'pmid': '17760646', 'type': 'BACKGROUND', 'citation': 'Kent-Smith BT, Wallace GM. Routine cataract surgery without the presence of an anaesthetist. 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CAM Journal 10, 31-36, doi:10.1177/1525822x980100020301 (2016).'}, {'type': 'BACKGROUND', 'citation': 'Hays, D. G. & Singh, A. A. in Qualitative Inquiry in Clinical and Educational Settings Ch. 10, 292-336 (Guilford Press, 2011).'}, {'pmid': '28851459', 'type': 'BACKGROUND', 'citation': 'Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this pilot clinical trial comparing two different sedation approaches for cataract surgery is to assess patient satisfaction, the quality of recovery, and surgical outcomes as well as to evaluate the overall feasibility and acceptability of the study protocol for the purpose of planning a larger clinical trial. Participants will be asked to respond to several surveys throughout the study on their experience and to assess outcomes of interest.', 'detailedDescription': 'This is a single-center, randomized, double-blinded, pilot clinical trial (n=20). Participants having first eye cataract surgery will be randomized to receive an oral benzodiazepine (intervention) or an oral placebo pill (control). The primary goal of this study is to compare differences in patient satisfaction, quality of recovery and surgical outcomes in participants receiving oral sedation versus oral placebo for cataract surgery. The secondary goals of this study are to assess success with recruitment, intervention fidelity, adherence to interventions and participant retention after interventions. Participants will be asked to respond to several surveys at key study timepoints regarding their sedation experiences and to assess outcomes of interest.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. ≥ 60 years old\n2. Capable of providing informed consent and completing the study procedures in English\n3. Able to provide consent for oneself\n4. Able to follow directions\n5. Able to climb one flight of stairs without stopping to rest\n6. Have a new diagnosis of cataract disease\n7. Plan on having cataract surgery on their eye within the next 6 months\n\nExclusion Criteria:\n\n1. History of prior cataract surgery\n2. Admission to the hospital within the past 30 days\n3. Difficulty being sedated during other minor outpatient procedures or imaging studies\n4. Allergy or resistance to local anesthetic agents\n5. Cannot lay flat on your back without having symptoms (i.e., difficulty breathing, severe back pain, etc.)\n6. History of severe anxiety requiring routine use of benzodiazepines\n7. Severe valve disease (e.g., critical aortic stenosis)\n8. Cardiac conditions requiring an implanted cardiac device such as a pacemaker, defibrillator, or left ventricular assist device (for arrhythmia, congestive heart failure, etc.)\n9. Untreated chest pain or angina\n10. Patients with movement disorders (e.g., Parkinson's Disease)\n11. History of Cerebral Vascular Accident (CVA), Transient Ischemic Attack (TIA), or seizures\n12. Require home oxygen (O2) at rest or with exertion\n13. End-stage renal disease (ESRD) requiring dialysis\n14. Morbid obesity (BMI\\>35)\n15. Patient undergoing cataract surgery in combination with any other ophthalmologic procedure\n16. Patient requiring general anesthesia during cataract surgery due to the underlying characteristics of the existing cataract and/or anticipated complexity of the planned procedure"}, 'identificationModule': {'nctId': 'NCT06506669', 'acronym': 'CaTNAPS-1', 'briefTitle': 'Cataract Monitored Anesthesia Care (MAC) Feasibility Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Comparing Two Normal Approaches to Procedural Sedation for Cataract Surgery: A Prospective, Feasibility Pilot Study', 'orgStudyIdInfo': {'id': '23-40367'}, 'secondaryIdInfos': [{'id': '5K23AG072035-03', 'link': 'https://reporter.nih.gov/quickSearch/5K23AG072035-03', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Oral sedation will be administered to patients prior to the procedure.', 'interventionNames': ['Procedure: Oral sedation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'An oral placebo pill will be administered to patients prior to the procedure.', 'interventionNames': ['Procedure: Placebo']}], 'interventions': [{'name': 'Oral sedation', 'type': 'PROCEDURE', 'description': 'Oral medication for anxiolysis administered in the preoperative setting', 'armGroupLabels': ['Intervention']}, {'name': 'Placebo', 'type': 'PROCEDURE', 'description': 'A placebo pill with no active ingredients administered in the preoperative setting', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Catherine L Chen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is a small single center pilot study so we do not plan to make individual participant data available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}