An interventional study of High IOP Setting and Low IOP Setting in Cataract and IOL Surgery, Cataract Surgery Anesthesia and Cataract Surgery Experience, sponsored by Matthew Rauen. Not yet recruiting at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-11-10.
Sponsored by Matthew Rauen · Not applicable, Interventional, and Supportive care
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's planned enrollment of 85 is close to the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Matthew Rauen is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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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:
Exclusion Criteria:
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.
Device: High IOP Setting
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.
Device: Low IOP Setting
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
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
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — We will share informed consent and study protocol.
Supporting information: Study protocol, Icf
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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