Less Discomfort and Less Pharmacology. Cataract Surgery at Physiologic Intraocular Pressure (IOP)

To investigate the impact of high vs low Intraocular Pressure (IOP) on the intraoperative experience for the patient and surgeon. Operating at a more physiologic IOP using Active Sentry hand piece during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication

Study Overview

• Status: Recruiting
• Conditions: Nuclear Cataract
• Intervention / Treatment: Other: High Intraocular Pressure (IOP); Other: Low Intraocular Pressure (IOP)

Detailed Description

Objectives:

To investigate the impact of Intraocular Pressure (IOP) high vs low on the intraoperative experience for the patient and surgeon

Design:

Prospective, single-surgeon, subject's first eyes undergoing phacoemulsification will be randomized to high (Intraocular Pressure (IOP) 65 millimeters of mercury (mmHg)) or low (IOP 25mmHg) IOP, contralateral eye will receive other treatment

Hypothesis:

Operating at a more physiologic IOP using Active Sentry hand piece during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: Robyn Kohler, RN; Phone Number: 2305 515-223-8685; Email: rkohler@wolfeclinic.com
• Study Contact Backup: Name: Hillery Joiner; Phone Number: 515-223-8685; Email: hjoiner@wolfeclinic.com

Study Locations

• United States
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Recruiting
      • Wolfe Eye Clinic
      • Contact: Hillery Joiner; Phone Number: 2085 5152238685; Email: hjoiner@wolfeclinic.com
      • Contact: Robyn Kohler, RN; Phone Number: 2305 515-223-8685; Email: rkohler@wolfeclinic.com
      • Principal Investigator: Matthew Rauen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

75 cataract surgery patients from ophthalmology clinic

Description

Inclusion Criteria:

• Visually significant cataract 2-3+ undergoing uncomplicated cataract surgery
• Unremarkable ocular health but inclusive of early Age related macular degeneration (AMD).

Exclusion Criteria:

• History of ocular surgery including corneal refractive surgery
• Compromised zonular integrity or stability
• Uncontrolled diabetes and diabetic retinopathy
• Small pupils
• History of systemic inflammatory disease/uveitis
• History of psychiatric illness, chronic pain/narcotics, benzodiazepine usage
• Abnormal liver or renal function

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
High Intraocular Pressure (IOP); Eyes in this arm will maintain an Intraocular Pressure (IOP) of 65 millimeters of mercury (mmHg) throughout the cataract surgery.	Other: High Intraocular Pressure (IOP); Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with Intraocular Pressure (IOP) ≤ 24 millimeters of mercury (mmHg) (low IOP) in one eye and with IOP ≥ 65 millimeters of mercury (mmHg) (high IOP) in the other eye.
Low Intraocular Pressure (IOP); Eyes in this arm will maintain an Intraocular Pressure (IOP) of 24 millimeters of mercury (mmHg) throughout the cataract surgery.	Other: Low Intraocular Pressure (IOP); Low Intraocular Pressure (IOP) Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with intraocular IOP ≤ 24 millimeters of mercury (mmHg) (low IOP) in one eye and with IOP ≥ 65 millimeters of mercury (mmHg) (high IOP) in the other eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Rescue	Percentage (%) of pts in each group requiring treatment for breakthrough discomfort/pain	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiologic Responses associated with pain/inflammation:	Blood pressure- measured systolic pressure over the diastolic pressure	Intraoperative
Physiologic Responses associated with pain/inflammation:	Pulse rate- measured in beats per minute (bpm)	Intraoperative
Surgeon Experience: Assessment on patient cooperation	Surgeon assessment on patient cooperation: poor, good, excellent; Poor cooperation: could not follow instructions, lid squeezing, patient had frequent eye & head movements; Good cooperation: able to follow directions 50% of the time, some lid squeezing and patient movement; Excellent cooperation: able to follow directions >80% of the time with limited lid squeezing and patient movement	Intraoperative
Surgeon Experience: Surgeon intraoperative experience	Surgeon assessment on overall experience: poor, good, excellent; Poor: fluctuating chamber (reverse pupillary block or surge) and reduced efficiency (nucleus & cortex removal); Good: >75% chamber stability and adequate efficiency; Excellent: Minimal to no fluctuating chamber and excellent efficiency	Intraoperative
Cost- analysis	Cost-analysis on intraoperative pharmacological agents utilized between high vs low Intraocular Pressure (IOP)	Intraoperative

Collaborators and Investigators

• Sponsor: Matthew Rauen

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: IIT #88313865

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No