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

Matthew Rauen

Status: Completed

Conditions: Nuclear Cataract

Treatments: Other: High Intraocular Pressure (IOP); Other: Low Intraocular Pressure (IOP)

Study type: Observational

Funder types: Other

Identifiers

NCT06325397

IIT #88313865

Details and patient eligibility

About

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

Full 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

Enrollment: 65 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

65 participants in 2 patient groups

High Intraocular Pressure (IOP)

Description:

Eyes in this arm will maintain an Intraocular Pressure (IOP) of 65 millimeters of mercury (mmHg) throughout the cataract surgery.

Treatment:

Other: High Intraocular Pressure (IOP)

Low Intraocular Pressure (IOP)

Description:

Eyes in this arm will maintain an Intraocular Pressure (IOP) of 24 millimeters of mercury (mmHg) throughout the cataract surgery.

Treatment:

Other: Low Intraocular Pressure (IOP)