The Impact of Physiologic Cataract Surgery on Patient Comfort and Medication Usage

Part of paid clinical trials in West Des Moines, Iowa.

Sponsor
Matthew Rauen
Study ID
NCT07223866
Status
Not Yet Recruiting

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Conditions

  • Cataract Surgery Anesthesia
  • Cataract Surgery Experience
  • Cataract and IOL Surgery
  • Nuclear Cataract

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • High IOP Setting — DEVICE
    Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to low (IOP 25mmHg) or high (IOP 65mmHg) IOP, contralateral eye will receive other treatment
  • Low IOP Setting — DEVICE
    Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to low (IOP 25mmHg) or high (IOP 65mmHg) IOP, contralateral eye will receive other treatment

Study Details

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.

Key Dates

Start date
Nov 1, 2025
Status verified
Nov 2025
Primary completion
Nov 1, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
85 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Centurion with Active Sentry at a traditionally high IOP setting
    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.
  • Active Comparator: Unity VCS/CS with Intelligent Fluidics at a low 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.

Primary Outcome Measure

Rescue Medication [ Time Frame: During cataract surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wolfe Eye Clinic and Wolfe Surgery CenterWest Des MoinesIowa50266
Robyn Kohler, RN
[email protected]
515-223-8685

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By research site
Wolfe Eye Clinic and Wolfe Surgery Center· West Des Moines, IA

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