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NCT Number: NCT07223866

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

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.

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Key information

Conditions

Cataract and IOL Surgery Cataract Cataract Surgery Anesthesia Cataract Surgery Experience Eye Diseases Lens Diseases Nuclear Cataract

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wolfe Eye Clinic and Wolfe Surgery Center

West Des Moines, Iowa, 50266, United States

Location contact

Robyn Kohler, RN

CONTACT

[email protected]

515-223-8685

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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 criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. Rescue Medication

    Time frame: During cataract surgery

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

Secondary outcomes

  1. VAS Pain Score

    Time frame: During Phaco, I/A, and Visco Removal

    Discomfort/pain score at phaco, I/A, visco removal. VAS score : 0 - no pain, 10 - unbearable pain

  2. Surgeon Intraoperative Experience

    Time frame: During cataract surgery

    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

  3. Cost Analysis

    Time frame: During cataract surgery

    Cost-analysis on intraoperative medications utilized in high vs low IOP groups

  4. Breakthrough pain and discomfort High Axial Length

    Time frame: During cataract surgery

    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.

  5. 1 day Post Op Patient Survey

    Time frame: 1 day post op cataract surgery, each eye

    • 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

  6. Anesthesiologist Review Blood Pressure

    Time frame: During cataract surgery

    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.

  7. Anesthesiologist Review Pulse Rate

    Time frame: During cataract surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Robyn Kohler, RN

CONTACT

[email protected]

515-223-8685

Sponsors and collaborators

Lead sponsor

Matthew Rauen

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 3, 2025
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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