Cataract Monitored Anesthesia Care (MAC) Feasibility Pilot Study

NCT06506669 | Completed Results

• 2 other identifiers: 23-403675K23AG072035-03
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot clinical trial comparing two different sedation approaches for cataract surgery is to assess the feasibility, completeness, and distribution of data in measuring patient satisfaction, the quality of recovery, and surgical outcomes 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.

Conditions

Cataract; Anesthesia; Bilateral Senile Cataract; Patient Satisfaction

Keywords

cataract surgery; oral sedation; intravenous sedation; conscious sedation; monitored anesthesia care; quality of recovery

Outcome Measures

Primary Outcomes (1)

• Number of Participants With High Satisfaction (ISAS Score ≥ 2)

  The Iowa Satisfaction with Anesthesia Scale (ISAS) is an 11-item validated questionnaire assessing patient satisfaction with anesthesia care. Each item is scored from -3 to +3, and the total score is calculated as the mean of all items, resulting in a total score range of -3 to +3. Higher scores indicate greater satisfaction. For this analysis, high satisfaction is defined as an ISAS score ≥ 2.

  30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)

Secondary Outcomes (7)

• Number of Participants Meeting Eligibility Criteria at Screening

  At screening (prior to enrollment)

• Number of Participants Completing All Study Surveys at Each Timepoint

  30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)

• Number of Participants Who Completed All Required Study Procedures

  From enrollment through final study follow-up (POD7)

• Number of Participants With Sedation-Related Complications During 30-Day Postoperative Follow-up

  From enrollment through 30 days after surgery

• Number of Participants Achieving Recovery on the Postoperative Quality of Recovery Scale (PQRS)

  30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)

Study Arms (2)

Intervention

EXPERIMENTAL

Oral sedation will be administered to patients prior to the procedure.

Procedure: Oral sedation

Placebo

PLACEBO COMPARATOR

An oral placebo pill will be administered to patients prior to the procedure.

Procedure: Placebo

Interventions

Oral sedation PROCEDURE

Oral medication for anxiolysis administered in the preoperative setting

Intervention

Placebo PROCEDURE

A placebo pill with no active ingredients administered in the preoperative setting

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 60 years old
• Capable of providing informed consent and completing the study procedures in English
• Able to provide consent for oneself
• Able to follow directions
• Able to climb one flight of stairs without stopping to rest
• Have a new diagnosis of cataract disease
• Plan on having cataract surgery on their eye within the next 6 months

You may not qualify if:

• History of prior cataract surgery
• Admission to the hospital within the past 30 days
• Difficulty being sedated during other minor outpatient procedures or imaging studies
• Allergy or resistance to local anesthetic agents
• Cannot lay flat on your back without having symptoms (i.e., difficulty breathing, severe back pain, etc.)
• History of severe anxiety requiring routine use of benzodiazepines
• Severe valve disease (e.g., critical aortic stenosis)
• Cardiac conditions requiring an implanted cardiac device such as a pacemaker, defibrillator, or left ventricular assist device (for arrhythmia, congestive heart failure, etc.)
• Untreated chest pain or angina
• Patients with movement disorders (e.g., Parkinson's Disease)
• History of Cerebral Vascular Accident (CVA), Transient Ischemic Attack (TIA), or seizures
• Require home oxygen (O2) at rest or with exertion
• End-stage renal disease (ESRD) requiring dialysis
• Morbid obesity (BMI\>35)
• Patient undergoing cataract surgery in combination with any other ophthalmologic procedure

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• University of California, San Francisco: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (51)

• 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: 25875258 BACKGROUND

• 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: 29346472 BACKGROUND

• 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.

  PMID: 28242111 BACKGROUND

• 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).

  BACKGROUND

• Kent, C. Cataract Surgery: Is an anesthesiologist necessary?, <https://www.reviewofophthalmology.com/article/cataract-surgery-is-an-anesthesiologist-necessary> (2009).

  BACKGROUND

• 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).

  BACKGROUND

• 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: 26804760 BACKGROUND

• 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: 15691563 BACKGROUND

• Kent-Smith BT, Wallace GM. Routine cataract surgery without the presence of an anaesthetist. Clin Exp Ophthalmol. 2007 Aug;35(6):589. doi: 10.1111/j.1442-9071.2007.01553.x. No abstract available.

  PMID: 17760646 BACKGROUND

• Murray P, Adams K, Haddad P, Murray N, O'Rourke M. The routine requirement for anaesthetists in local anaesthetic cataract surgery. Clin Exp Ophthalmol. 2007 Mar;35(2):195-6. doi: 10.1111/j.1442-9071.2006.01441.x. No abstract available.

  PMID: 17362468 BACKGROUND

• Zakrzewski PA, Banashkevich AV, Friel T, Braga-Mele R. Monitored anesthesia care by registered respiratory therapists during cataract surgery: an update. Ophthalmology. 2010 May;117(5):897-902. doi: 10.1016/j.ophtha.2009.10.005. Epub 2010 Jan 15.

  PMID: 20079927 BACKGROUND

• Basta B, Gioia L, Gemma M, Dedola E, Bianchi I, Fasce F, Beretta L. Systemic adverse events during 2005 phacoemulsifications under monitored anesthesia care: a prospective evaluation. Minerva Anestesiol. 2011 Sep;77(9):877-83.

  PMID: 21878869 BACKGROUND

• Koolwijk J, Fick M, Selles C, Turgut G, Noordergraaf JI, Tukkers FS, Noordergraaf GJ. Outpatient cataract surgery: incident and procedural risk analysis do not support current clinical ophthalmology guidelines. Ophthalmology. 2015 Feb;122(2):281-7. doi: 10.1016/j.ophtha.2014.08.030. Epub 2014 Oct 22.

  PMID: 25444350 BACKGROUND

• Katz J, Feldman MA, Bass EB, Lubomski LH, Tielsch JM, Petty BG, Fleisher LA, Schein OD. Injectable versus topical anesthesia for cataract surgery: patient perceptions of pain and side effects. The Study of Medical Testing for Cataract Surgery study team. Ophthalmology. 2000 Nov;107(11):2054-60. doi: 10.1016/s0161-6420(00)00359-6.

  PMID: 11054331 BACKGROUND

• Katz J, Feldman MA, Bass EB, Lubomski LH, Tielsch JM, Petty BG, Fleisher LA, Schein OD; Study of Medical Testing for Cataract Surgery Study Team. Adverse intraoperative medical events and their association with anesthesia management strategies in cataract surgery. Ophthalmology. 2001 Oct;108(10):1721-6. doi: 10.1016/s0161-6420(01)00704-7.

  PMID: 11581040 BACKGROUND

• Fukuoka H, Afshari NA. The impact of age-related cataract on measures of frailty in an aging global population. Curr Opin Ophthalmol. 2017 Jan;28(1):93-97. doi: 10.1097/ICU.0000000000000338.

  PMID: 27820747 BACKGROUND

• American Society of Anesthesiologists. ASA Calls on Anthem to Rescind Its New Policy on Anesthesia for Cataract Surgery, <https://www.asahq.org/advocacy-and-asapac/fda-and-washington-alerts/washington-alerts/2018/02/asa-calls-on-anthem-to-rescind-its-new-policy-on-anesthesia-for-cataract-surgery?&ct=fd2b35b6cdb74e0b126f4539b73b56360091233e85002bc197d8049fa56b7a4253b022b37557ad25186cfc15475fa96cd09811e97c66fe62b04a1ec1298f82ef> (2018).

  BACKGROUND

• American Academy of Ophthalmology. Pressure on Anthem Grows; Academy Keeps Pushing for Cataract-Surgery Anesthesia Coverage, 2018).

  BACKGROUND

• Partridge JS, Harari D, Dhesi JK. Frailty in the older surgical patient: a review. Age Ageing. 2012 Mar;41(2):142-7. doi: 10.1093/ageing/afr182.

  PMID: 22345294 BACKGROUND

• Hubbard RE, Story DA. Patient frailty: the elephant in the operating room. Anaesthesia. 2014 Jan;69 Suppl 1:26-34. doi: 10.1111/anae.12490.

  PMID: 24303858 BACKGROUND

• McIsaac DI, MacDonald DB, Aucoin SD. Frailty for Perioperative Clinicians: A Narrative Review. Anesth Analg. 2020 Jun;130(6):1450-1460. doi: 10.1213/ANE.0000000000004602.

  PMID: 32384334 BACKGROUND

• Kim DH, Patorno E, Pawar A, Lee H, Schneeweiss S, Glynn RJ. Measuring Frailty in Administrative Claims Data: Comparative Performance of Four Claims-Based Frailty Measures in the U.S. Medicare Data. J Gerontol A Biol Sci Med Sci. 2020 May 22;75(6):1120-1125. doi: 10.1093/gerona/glz224.

  PMID: 31566201 BACKGROUND

• Kim DH, Schneeweiss S, Glynn RJ, Lipsitz LA, Rockwood K, Avorn J. Measuring Frailty in Medicare Data: Development and Validation of a Claims-Based Frailty Index. J Gerontol A Biol Sci Med Sci. 2018 Jun 14;73(7):980-987. doi: 10.1093/gerona/glx229.

  PMID: 29244057 BACKGROUND

• Hodge W, Horsley T, Albiani D, Baryla J, Belliveau M, Buhrmann R, O'Connor M, Blair J, Lowcock E. The consequences of waiting for cataract surgery: a systematic review. CMAJ. 2007 Apr 24;176(9):1285-90. doi: 10.1503/cmaj.060962.

  PMID: 17452662 BACKGROUND

• Iroku-Malize T, Kirsch S. Eye Conditions in Older Adults: Cataracts. FP Essent. 2016 Jun;445:17-23.

  PMID: 27348528 BACKGROUND

• Owsley C, McGwin G Jr, Sloane M, Wells J, Stalvey BT, Gauthreaux S. Impact of cataract surgery on motor vehicle crash involvement by older adults. JAMA. 2002 Aug 21;288(7):841-9. doi: 10.1001/jama.288.7.841.

  PMID: 12186601 BACKGROUND

• Hillman, L. Phaco turns 50, <https://www.eyeworld.org/phaco-turns-50> (2017).

  BACKGROUND

• Eke T, Thompson JR. Serious complications of local anaesthesia for cataract surgery: a 1 year national survey in the United Kingdom. Br J Ophthalmol. 2007 Apr;91(4):470-5. doi: 10.1136/bjo.2006.106005. Epub 2006 Nov 23.

  PMID: 17124243 BACKGROUND

• Jefferis JM, Clarke MP, Taylor JP, Brittain KR. Challenges for the cataract surgeon treating people with dementia: a qualitative study exploring anesthetic choices. Clin Ophthalmol. 2014 Sep 26;8:1993-9. doi: 10.2147/OPTH.S69388. eCollection 2014.

  PMID: 25328382 BACKGROUND

• Norregaard JC, Bernth-Petersen P, Bellan L, Alonso J, Black C, Dunn E, Andersen TF, Espallargues M, Anderson GF. Intraoperative clinical practice and risk of early complications after cataract extraction in the United States, Canada, Denmark, and Spain. Ophthalmology. 1999 Jan;106(1):42-8. doi: 10.1016/s0161-6420(99)90004-0.

  PMID: 9917779 BACKGROUND

• Sharwood PL, Thomas D, Roberts TV. Adverse medical events associated with cataract surgery performed under topical anaesthesia. Clin Exp Ophthalmol. 2008 Dec;36(9):842-6. doi: 10.1111/j.1442-9071.2009.01924.x.

  PMID: 19278479 BACKGROUND

• Stein JD, Grossman DS, Mundy KM, Sugar A, Sloan FA. Severe adverse events after cataract surgery among medicare beneficiaries. Ophthalmology. 2011 Sep;118(9):1716-23. doi: 10.1016/j.ophtha.2011.02.024. Epub 2011 Jun 2.

  PMID: 21640382 BACKGROUND

• Rocha G, Turner C. Safety of cataract surgery under topical anesthesia with oral sedation without anesthetic monitoring. Can J Ophthalmol. 2007 Apr;42(2):288-94.

  PMID: 17392854 BACKGROUND

• California Medical Association. CMA calls for investigation into Anthem restricting use of sedation during cataract surgery, <https://www.cmadocs.org/newsroom/news/view/ArticleID/21466/t/CMA-calls-for-investigation-into-Anthem-policy-restricting-use-of-sedation-during-cataract-surgery> (2018).

  BACKGROUND

• Rosenfeld, S. Monitored Anesthesia Care in Cataract Surgery, <https://www.aao.org/eyenet/article/monitored-anesthesia-care-in-cataract-surgery> (2018).

  BACKGROUND

• Dent E, Kowal P, Hoogendijk EO. Frailty measurement in research and clinical practice: A review. Eur J Intern Med. 2016 Jun;31:3-10. doi: 10.1016/j.ejim.2016.03.007. Epub 2016 Mar 31.

  PMID: 27039014 BACKGROUND

• Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.

  PMID: 16129869 BACKGROUND

• Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

  PMID: 11253156 BACKGROUND

• Whitlock EL, Whittington RA. The Frailty Syndrome: Anesthesiologists Must Understand More and Fear Less. Anesth Analg. 2020 Jun;130(6):1445-1448. doi: 10.1213/ANE.0000000000004789. No abstract available.

  PMID: 32384332 BACKGROUND

• Fleisher LA, Fleischmann KE, Auerbach AD, Barnason SA, Beckman JA, Bozkurt B, Davila-Roman VG, Gerhard-Herman MD, Holly TA, Kane GC, Marine JE, Nelson MT, Spencer CC, Thompson A, Ting HH, Uretsky BF, Wijeysundera DN. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines. Developed in collaboration with the American College of Surgeons, American Society of Anesthesiologists, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Anesthesiologists, and Society of Vascular Medicine Endorsed by the Society of Hospital Medicine. J Nucl Cardiol. 2015 Feb;22(1):162-215. doi: 10.1007/s12350-014-0025-z. No abstract available.

  PMID: 25523415 BACKGROUND

• Aarons GA, Hurlburt M, Horwitz SM. Advancing a conceptual model of evidence-based practice implementation in public service sectors. Adm Policy Ment Health. 2011 Jan;38(1):4-23. doi: 10.1007/s10488-010-0327-7.

  PMID: 21197565 BACKGROUND

• Glisson C, Landsverk J, Schoenwald S, Kelleher K, Hoagwood KE, Mayberg S, Green P; Research Network on Youth Mental Health. Assessing the organizational social context (OSC) of mental health services: implications for research and practice. Adm Policy Ment Health. 2008 Mar;35(1-2):98-113. doi: 10.1007/s10488-007-0148-5. Epub 2007 Dec 18.

  PMID: 18085434 BACKGROUND

• Hays, D. G. & Singh, A. A. Qualitative inquiry in clinical and educational settings. (Guilford Press, 2012).

  BACKGROUND

• Saunders B, Sim J, Kingstone T, Baker S, Waterfield J, Bartlam B, Burroughs H, Jinks C. Saturation in qualitative research: exploring its conceptualization and operationalization. Qual Quant. 2018;52(4):1893-1907. doi: 10.1007/s11135-017-0574-8. Epub 2017 Sep 14.

  PMID: 29937585 BACKGROUND

• Francis JJ, Johnston M, Robertson C, Glidewell L, Entwistle V, Eccles MP, Grimshaw JM. What is an adequate sample size? Operationalising data saturation for theory-based interview studies. Psychol Health. 2010 Dec;25(10):1229-45. doi: 10.1080/08870440903194015.

  PMID: 20204937 BACKGROUND

• Nilsen P. Making sense of implementation theories, models and frameworks. Implement Sci. 2015 Apr 21;10:53. doi: 10.1186/s13012-015-0242-0.

  PMID: 25895742 BACKGROUND

• Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.

  PMID: 19664226 BACKGROUND

• Guest, G., MacQueen, K. M. & Namey, E., E. Applied Thematic Analysis. (Sage Publications, 2011).

  BACKGROUND

• MacQueen, K. M., McLellan, E., Kay, K. & Milstein, B. Codebook Development for Team-Based Qualitative Analysis. CAM Journal 10, 31-36, doi:10.1177/1525822x980100020301 (2016).

  BACKGROUND

• Hays, D. G. & Singh, A. A. in Qualitative Inquiry in Clinical and Educational Settings Ch. 10, 292-336 (Guilford Press, 2011).

  BACKGROUND

• 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.

  PMID: 28851459 BACKGROUND

MeSH Terms

Conditions

Cataract; Patient Satisfaction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

This pilot study was limited by a small sample size and was not powered to detect statistically significant differences between study arms. Recruitment was extended due to external factors and a limited number of participating surgeons with restricted operating days, which constrained enrollment. The study was conducted at a single academic center, limiting generalizability, and some enrolled participants were not randomized due to day-of-surgery external factors, further reducing the sample.

Results Point of Contact

• Title: Catherine Chen
• Organization: University of California, San Francisco

Catherine.Chen@ucsf.edu

415-476-0683

Study Officials

• Catherine L Chen, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-center, randomized, double-blinded, randomized pilot clinical trial

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 17, 2024
• Study Start: June 12, 2024
• Primary Completion: May 6, 2025
• Study Completion: May 29, 2025
• Last Updated: July 9, 2026
• Results First Posted: July 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)