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

NCT07223866 | Not Yet Recruiting FDA Device

• 1 other identifier: IIT #98621123
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract and IOL Surgery; Cataract Surgery Anesthesia; Cataract Surgery Experience; Nuclear Cataract

Outcome Measures

Primary Outcomes (1)

• Rescue Medication

  Percent of pts in each group requiring rescue medication for breakthrough discomfort/pain

  During cataract surgery

Secondary Outcomes (7)

• VAS Pain Score

  During Phaco, I/A, and Visco Removal

• Surgeon Intraoperative Experience

  During cataract surgery

• Cost Analysis

  During cataract surgery

• Breakthrough pain and discomfort High Axial Length

  During cataract surgery

• 1 day Post Op Patient Survey

  1 day post op cataract surgery, each eye

Study Arms (2)

Centurion with Active Sentry at a traditionally high IOP setting

ACTIVE COMPARATOR

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

Unity VCS/CS with Intelligent Fluidics at a low IOP setting

ACTIVE COMPARATOR

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

Interventions

High IOP Setting DEVICE

Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to low (IOP 25mmHg) or high (IOP 65mmHg) IOP, contralateral eye will receive other treatment

Centurion with Active Sentry at a traditionally high IOP setting

Low IOP Setting DEVICE

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

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Matthew Rauen: lead

Study Sites (1)

Wolfe Eye Clinic and Wolfe Surgery Center

West Des Moines, Iowa, 50266, United States

Location

Related Publications (6)

• 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.

  PMID: 30528516 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 34860481 BACKGROUND

• 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.

  PMID: 34737914 BACKGROUND

• 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.

  PMID: 9917782 BACKGROUND

• 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.

  PMID: 9209989 BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Central Study Contacts

Robyn Kohler, RN

CONTACT

515-223-8685; rkohler@wolfeclinic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Study treatment \& Methods: * 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

Study Record Dates

• First Submitted: October 20, 2025
• First Posted: November 3, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Will provide with this submission.
• 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

Locations

US (1)