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

NCT06325397 | Completed

• 1 other identifier: IIT #88313865
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nuclear Cataract

Outcome Measures

Primary Outcomes (1)

• Medication Rescue

  Percentage (%) of pts in each group requiring treatment for breakthrough discomfort/pain

  Intraoperative

Secondary Outcomes (5)

• Physiologic Responses associated with pain/inflammation:

  Intraoperative

• Physiologic Responses associated with pain/inflammation:

  Intraoperative

• Surgeon Experience: Assessment on patient cooperation

  Intraoperative

• Surgeon Experience: Surgeon intraoperative experience

  Intraoperative

• Cost- analysis

  Intraoperative

Study Arms (2)

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)

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)

Interventions

High Intraocular Pressure (IOP) OTHER

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.

High Intraocular Pressure (IOP)

Low Intraocular Pressure (IOP) OTHER

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

Low Intraocular Pressure (IOP)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

75 cataract surgery patients from ophthalmology clinic

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Matthew Rauen: lead

Study Sites (1)

Wolfe Eye Clinic

West Des Moines, Iowa, 50266, United States

Location

Related Publications (3)

• 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

• 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

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: March 22, 2024
• Study Start: March 18, 2024
• Primary Completion: December 20, 2024
• Study Completion: April 1, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)