The Impact of Physiologic Cataract Surgery on Patient Comfort and Medication Usage

The study will pertain to investigating the impact of high vs low IOP on the intraoperative experience and comfort for the patient and surgeon. Our hypothesis is that operating at a more physiological IOP using Unity VCS/CS and Centurion with Active Sentry at a higher, or more traditional IOP will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication and lower VAS scores.

Study Overview

• Status: Not yet recruiting
• Conditions: Nuclear Cataract; Cataract Surgery Anesthesia; Cataract and IOL Surgery; Cataract Surgery Experience
• Intervention / Treatment: Device: High IOP Setting; Device: Low IOP Setting

Detailed Description

Objective/ Unmet Medical Need:

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.

• Study Type: Interventional
• Enrollment (Estimated): 85
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robyn Kohler, RN; Phone Number: 515-223-8685; Email: rkohler@wolfeclinic.com

Study Locations

• United States
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Wolfe Eye Clinic and Wolfe Surgery Center
      • Contact: Robyn Kohler, RN; Phone Number: 515-223-8685; Email: rkohler@wolfeclinic.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: Subjects who will require bilateral cataract surgery will be considered. Evaluations will occur in the clinic of the Principal Investigator (PI) Matthew Rauen, MD at the Wolfe Eye Clinic.

Inclusion Criteria:

• Visually significant cataract 2-3+ undergoing uncomplicated cataract surgery with similar cataract grade in both eyes
• Unremarkable ocular health but inclusive of early AMD

Exclusion Criteria:

• H/o ocular surgery including corneal refractive surgery
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: 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
Active Comparator: 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.	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rescue Medication	Percent of pts in each group requiring rescue medication for breakthrough discomfort/pain	During cataract surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS Pain Score	Discomfort/pain score at phaco, I/A, visco removal. VAS score : 0 - no pain, 10 - unbearable pain	During Phaco, I/A, and Visco Removal
Surgeon Intraoperative Experience	1- Poor: fluctuating chamber (reverse pupillary block or surge) and reduced efficiency (nucleus & cortex removal); 2- Good: >75% chamber stability and adequate efficiency; 3- Excellent: Minimal to no fluctuating chamber and excellent efficiency	During cataract surgery
Cost Analysis	Cost-analysis on intraoperative medications utilized in high vs low IOP groups	During cataract surgery
Breakthrough pain and discomfort High Axial Length	VAS Pain score on subjects with axial length of >24.5mm VAS score : 0 - no pain, 10 - unbearable pain If patients experienced breakthrough pain during surgery, additional topical anesthetic, intracameral lidocaine, and/or opioid will be used per surgeon discretion and stage of surgery recorded.	During cataract surgery
1 day Post Op Patient Survey	on experience (Iowa Satisfaction with Anesthesia Scale (ISAS); on patient preference - What eye was more comfortable? (R/L); surgical experience did you enjoy more? (R/L); x% of eyes would undergo the same procedure again; x% of eyes would recommend the procedure to family and friends	1 day post op cataract surgery, each eye
Anesthesiologist Review Blood Pressure	Physiological responses recorded: Anesthesiologist will monitor patients per standard of care but will record additional Blood Pressure values at the start of the case (room entry), 4 minutes after versed is administered, during phacoemulsification, and during viscoelastic removal.	During cataract surgery
Anesthesiologist Review Pulse Rate	Physiological responses recorded: Anesthesiologist will monitor patients per standard of care but will record additional Pulse Rate values at the start of the case (room entry), 4 minutes after versed is administered, during phacoemulsification, and during viscoelastic removal.	During cataract surgery

Collaborators and Investigators

• Sponsor: Matthew Rauen

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: October 20, 2025
• First Submitted That Met QC Criteria: October 30, 2025
• First Posted (Estimated): November 3, 2025

Study Record Updates

• Last Update Posted (Actual): November 10, 2025
• Last Update Submitted That Met QC Criteria: November 5, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: IIT #98621123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share informed consent and study protocol.
• IPD Sharing Time Frame: Will provide with this submission.
• IPD Sharing Access Criteria: No patient specific data analysis will be shared. Will supply copies of IRB approved informed consent and protocol. Inquires to be sent to rkohler@wolfeclinic.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No