Status:
NOT_YET_RECRUITING
The Impact of Physiologic Cataract Surgery on Patient Comfort and Medication Usage
Lead Sponsor:
Matthew Rauen
Conditions:
Cataract and IOL Surgery
Cataract Surgery Anesthesia
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
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...
Detailed Description
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 int...
Eligibility Criteria
Inclusion
- 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.
- Visually significant cataract 2-3+ undergoing uncomplicated cataract surgery with similar cataract grade in both eyes
- Unremarkable ocular health but inclusive of early AMD
Exclusion
- H/o ocular surgery including corneal refractive surgery
- Compromised zonular integrity or stability
- Uncontrolled diabetes and diabetic retinopathy
- Small pupils
- H/o systemic inflammatory disease/uveitis
- H/o chronic pain medications (including narcotics) and benzodiazepine usage
- Abnormal liver or renal function
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT07223866
Start Date
November 1 2025
End Date
January 1 2027
Last Update
November 7 2025
Active Locations (1)
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1
Wolfe Eye Clinic and Wolfe Surgery Center
West Des Moines, Iowa, United States, 50266