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

Matthew Rauen

Status: Not yet enrolling

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

Treatments: Device: Low IOP Setting; Device: High IOP Setting

Study type: Interventional

Funder types: Other

Identifiers

NCT07223866

IIT #98621123

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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85 participants in 2 patient groups

Centurion with Active Sentry at a traditionally high IOP setting

Active Comparator group

Description:

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.

Treatment:

Device: High IOP Setting

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

Active Comparator group

Description:

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.

Treatment:

Device: Low IOP Setting