Cataract Surgery Comfort Study

This study is looking at how different pressure settings during cataract surgery affect your comfort. Specifically, it compares two ways to manage eye pressure (intraocular pressure or IOP) during surgery: a low IOP setting (25mmHg) using the Unity VCS/CS system and a higher, more traditional IOP setting (65mmHg) using the Centurion with Active Sentry system. The goal is to see if operating at a more natural, lower pressure leads to less discomfort or pain for you during the procedure. We'll measure this by how much pain medication you might need during surgery. You might be able to join if you are 60 years or older, need cataract surgery in both eyes, and have a similar type of cataract in each eye. The study is currently unclear on its recruitment status.

Study design
This is an interventional study where your eyes will be randomly assigned to receive either the low or high IOP treatment during cataract surgery. About 85 participants are planned for this study.
What's involved
You would undergo cataract surgery for both eyes at the Wolfe Eye Clinic. Your comfort and need for pain medication will be assessed during the surgery.
Compensation
Not stated in the trial record.
Follow-up
Your need for rescue medication will be measured during cataract surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07223866

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

Not Yet Recruiting
NAAges 60+InterventionalSupportive care
Matthew Rauen
~85 participants
Updated 2025-11-10 on ClinicalTrials.gov
What's tested:High IOP SettingLow IOP Setting

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rescue Medication
Measured over During cataract surgery
Cataract and IOL Surgery
Cataract Surgery Anesthesia
Cataract Surgery Experience
Nuclear Cataract
1 sites across 1 states
Iowa1

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Eligibility criteria

Inclusion

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
  • Rescue MedicationDuring cataract surgery

    Percent of pts in each group requiring rescue medication for breakthrough discomfort/pain