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
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 Type
OBSERVATIONAL
Enrollment
65
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.
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
Wolfe Eye Clinic
West Des Moines, Iowa, United States
Medication Rescue
Percentage (%) of pts in each group requiring treatment for breakthrough discomfort/pain
Time frame: Intraoperative
Physiologic Responses associated with pain/inflammation:
Blood pressure- measured systolic pressure over the diastolic pressure
Time frame: Intraoperative
Physiologic Responses associated with pain/inflammation:
Pulse rate- measured in beats per minute (bpm)
Time frame: Intraoperative
Surgeon Experience: Assessment on patient cooperation
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
Time frame: Intraoperative
Surgeon Experience: Surgeon intraoperative experience
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
Time frame: Intraoperative
Cost- analysis
Cost-analysis on intraoperative pharmacological agents utilized between high vs low Intraocular Pressure (IOP)
Time frame: Intraoperative
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