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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
85
Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to low (IOP 25mmHg) or high (IOP 65mmHg) IOP, contralateral eye will receive other treatment
Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to low (IOP 25mmHg) or high (IOP 65mmHg) IOP, contralateral eye will receive other treatment
Wolfe Eye Clinic and Wolfe Surgery Center
West Des Moines, Iowa, United States
Rescue Medication
Percent of pts in each group requiring rescue medication for breakthrough discomfort/pain
Time frame: During cataract surgery
VAS Pain Score
Discomfort/pain score at phaco, I/A, visco removal. VAS score : 0 - no pain, 10 - unbearable pain
Time frame: During Phaco, I/A, and Visco Removal
Surgeon Intraoperative Experience
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: During cataract surgery
Cost Analysis
Cost-analysis on intraoperative medications utilized in high vs low IOP groups
Time frame: During cataract surgery
Breakthrough pain and discomfort High Axial Length
VAS Pain score on subjects with axial length of \>24.5mm VAS score : 0 - no pain, 10 - unbearable pain If patients experienced breakthrough pain during surgery, additional topical anesthetic, intracameral lidocaine, and/or opioid will be used per surgeon discretion and stage of surgery recorded.
Time frame: During cataract surgery
1 day Post Op Patient Survey
* on experience (Iowa Satisfaction with Anesthesia Scale (ISAS) * on patient preference - What eye was more comfortable? (R/L) * surgical experience did you enjoy more? (R/L) * x% of eyes would undergo the same procedure again * x% of eyes would recommend the procedure to family and friends
Time frame: 1 day post op cataract surgery, each eye
Anesthesiologist Review Blood Pressure
Physiological responses recorded: Anesthesiologist will monitor patients per standard of care but will record additional Blood Pressure values at the start of the case (room entry), 4 minutes after versed is administered, during phacoemulsification, and during viscoelastic removal.
Time frame: During cataract surgery
Anesthesiologist Review Pulse Rate
Physiological responses recorded: Anesthesiologist will monitor patients per standard of care but will record additional Pulse Rate values at the start of the case (room entry), 4 minutes after versed is administered, during phacoemulsification, and during viscoelastic removal.
Time frame: During cataract surgery
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