Less Discomfort and Less Pharmacology. Cataract Surgery at Physiologic Intraocular Pressure (IOP)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Nuclear Cataract
- Sponsor
- Matthew Rauen
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Medication Rescue
- Status
- Completed
- Last Updated
- 11 months ago
Overview
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
Investigators
Matthew Rauen
MD
Wolfe Eye Clinic
Eligibility Criteria
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
Outcomes
Primary Outcomes
Medication Rescue
Time Frame: Intraoperative
Percentage (%) of pts in each group requiring treatment for breakthrough discomfort/pain
Secondary Outcomes
- Surgeon Experience: Assessment on patient cooperation(Intraoperative)
- Cost- analysis(Intraoperative)
- Physiologic Responses associated with pain/inflammation:(Intraoperative)
- Surgeon Experience: Surgeon intraoperative experience(Intraoperative)