The Impact of Physiologic Cataract Surgery on Patient Comfort and Medication Usage
NCT ID: NCT07223866
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
85 participants
INTERVENTIONAL
2025-11-01
2027-01-01
Brief Summary
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Detailed Description
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To investigate the impact of Unity VCS/CS with Intelligent Fluidics at a low IOP setting and Centurion with Active Sentry at a traditionally high IOP setting on the intraoperative experience for the patient and surgeon. Limited research on phacoemulsification at near physiological IOP and its impact on patient discomfort/pain using the Unity VCS/CS system.
Design:
Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to high (IOP 65mmHg) or low (IOP 25mmHg) IOP, contralateral eye will receive other treatment.
STUDY HYPOTHESIS Unity VCS/CS with Intelligent Fluidics during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication and lower VAS scores.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Sequential cataract surgery with similar cataract grade 2-3+ based on LOCS III grading bilaterally; 2nd eye to be completed within 2-3 weeks of first eye
* Randomize first eye to low vs high IOP, contralateral eye receives opposite IOP
* Patient education on VAS with standard script
* Standard pre-op drops: 2 drops of cyclopentolate 1%, tropicamide 1%, flurbiprofen sodium (Ocufen 0.03%), phenylephrine hydrochloride 2.5%, and 3 drops of marcaine 0.05%
* After draping, patients receive OcuCoat on cornea and 3 drops of lidocaine, 1mg of Versed (midazolam for anxiety with no analgesic effects)
* If patients experienced breakthrough pain during surgery, additional topical anesthetic, intracameral lidocaine, and/or opioid will be used per surgeon discretion and stage recorded
* Physiological responses recorded: Anesthesiologist will monitor patients per standard of care but will record additional BP/HR values at the start of the case (room entry), 4 minutes
SUPPORTIVE_CARE
SINGLE
Study Groups
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Centurion with Active Sentry at a traditionally high IOP setting
Centurion with Active Sentry at a traditionally high IOP setting, Eyes in this arm will maintain an Intraocular Pressure (IOP) of 65 millimeters of mercury (mmHg) throughout the cataract surgery.
High IOP Setting
Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to low (IOP 25mmHg) or high (IOP 65mmHg) IOP, contralateral eye will receive other treatment
Unity VCS/CS with Intelligent Fluidics at a low IOP setting
Unity VCS/CS with Intelligent Fluidics at a low IOP setting. Eyes in this arm will maintain an Intraocular Pressure (IOP) of 25 millimeters of mercury (mmHg) throughout the cataract surgery.
Low IOP Setting
Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to low (IOP 25mmHg) or high (IOP 65mmHg) IOP, contralateral eye will receive other treatment
Interventions
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High IOP Setting
Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to low (IOP 25mmHg) or high (IOP 65mmHg) IOP, contralateral eye will receive other treatment
Low IOP Setting
Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to low (IOP 25mmHg) or high (IOP 65mmHg) IOP, contralateral eye will receive other treatment
Eligibility Criteria
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Inclusion Criteria
* Unremarkable ocular health but inclusive of early AMD
Exclusion Criteria
* Compromised zonular integrity or stability
* Uncontrolled diabetes and diabetic retinopathy
* Small pupils
* H/o systemic inflammatory disease/uveitis
* H/o chronic pain medications (including narcotics) and benzodiazepine usage
* Abnormal liver or renal function
60 Years
ALL
No
Sponsors
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Matthew Rauen
OTHER
Responsible Party
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Matthew Rauen
Principal Investigator
Locations
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Wolfe Eye Clinic and Wolfe Surgery Center
West Des Moines, Iowa, United States
Countries
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Central Contacts
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Facility Contacts
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Robyn Kohler, RN
Role: primary
References
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Liu YC, Setiawan M, Ang M, Yam GHF, Mehta JS. Changes in aqueous oxidative stress, prostaglandins, and cytokines: Comparisons of low-energy femtosecond laser-assisted cataract surgery versus conventional phacoemulsification. J Cataract Refract Surg. 2019 Feb;45(2):196-203. doi: 10.1016/j.jcrs.2018.09.022. Epub 2018 Dec 6.
Scarfone HA, Rodriquez EC. Evaluation of Early Changes of the Anterior Vitreous Interface after Cataract Surgery, using Low-Pressure Settings Determined by OCT. ASCRS 2023 May 6, San Diego Convention Center. https://ascrs.confex.com/ascrs/23am/meetingapp.cgi/Paper/88373
Donnenfeld ED, Mychajlyszyn D, Mychajlyszyn A, Stein R. Pain control and reduction of opioid use associated with intracameral phenylephrine1.0%-ketorolac 0.3% administered during cataract surgery. J Cataract Refract Surg. 2022 Jul 1;48(7):759-764. doi: 10.1097/j.jcrs.0000000000000855. Epub 2021 Oct 29.
Reddy AJ, Dang A, Dao AA, Arakji G, Cherian J, Brahmbhatt H. A Substantive Narrative Review on the Usage of Lidocaine in Cataract Surgery. Cureus. 2021 Oct 30;13(10):e19138. doi: 10.7759/cureus.19138. eCollection 2021 Oct.
Crandall AS, Zabriskie NA, Patel BC, Burns TA, Mamalis N, Malmquist-Carter LA, Yee R. A comparison of patient comfort during cataract surgery with topical anesthesia versus topical anesthesia and intracameral lidocaine. Ophthalmology. 1999 Jan;106(1):60-6. doi: 10.1016/S0161-6420(99)90007-6.
Gills JP, Cherchio M, Raanan MG. Unpreserved lidocaine to control discomfort during cataract surgery using topical anesthesia. J Cataract Refract Surg. 1997 May;23(4):545-50. doi: 10.1016/s0886-3350(97)80211-8.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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IIT #98621123
Identifier Type: -
Identifier Source: org_study_id