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

Completed

• Conditions: Nuclear Cataract

• Registration Number: NCT06325397
• Lead Sponsor: Matthew Rauen

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

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 Timeline

• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-03-15
• Study Start: 2024-03-18
• Study First Posted: 2024-03-22
• Primary Completion: 2024-12-20
• Study Completion: 2025-04-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Medication Rescue	Intraoperative	Percentage (%) of pts in each group requiring treatment for breakthrough discomfort/pain

Secondary Outcome Measures

Name	Time	Method
Surgeon Experience: Assessment on patient cooperation	Intraoperative	Surgeon assessment on patient cooperation: poor, good, excellent; 1. Poor cooperation: could not follow instructions, lid squeezing, patient had frequent eye \& head movements; 2. Good cooperation: able to follow directions 50% of the time, some lid squeezing and patient movement; 3. Excellent cooperation: able to follow directions \>80% of the time with limited lid squeezing and patient movement
Cost- analysis	Intraoperative	Cost-analysis on intraoperative pharmacological agents utilized between high vs low Intraocular Pressure (IOP)
Physiologic Responses associated with pain/inflammation:	Intraoperative	Pulse rate- measured in beats per minute (bpm)
Surgeon Experience: Surgeon intraoperative experience	Intraoperative	Surgeon assessment on overall experience: poor, good, excellent; 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

Trial Locations

Locations (1)

Wolfe Eye Clinic; 🇺🇸 West Des Moines, Iowa, United States