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OpenTrials
Completed

NCT Number: NCT06325397

Less Discomfort and Less Pharmacology. Cataract Surgery at Physiologic Intraocular Pressure (IOP)

To investigate the impact of high vs low Intraocular Pressure (IOP) on the intraoperative experience for the patient and surgeon. Operating at a more physiologic IOP using Active Sentry hand piece during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication

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Key information

Conditions

Nuclear Cataract

Sex eligibility

All sexes

Study type

Observational

Primary location

Wolfe Eye Clinic

West Des Moines, Iowa, 50266, United States

About this study

Objectives:

To investigate the impact of Intraocular Pressure (IOP) high vs low on the intraoperative experience for the patient and surgeon

Design:

Prospective, single-surgeon, subject's first eyes undergoing phacoemulsification will be randomized to high (Intraocular Pressure (IOP) 65 millimeters of mercury (mmHg)) or low (IOP 25mmHg) IOP, contralateral eye will receive other treatment

Hypothesis:

Operating at a more physiologic IOP using Active Sentry hand piece during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Visually significant cataract 2-3+ undergoing uncomplicated cataract surgery
  • Unremarkable ocular health but inclusive of early Age related macular degeneration (AMD).

Exclusion criteria

  • History of ocular surgery including corneal refractive surgery
  • Compromised zonular integrity or stability
  • Uncontrolled diabetes and diabetic retinopathy
  • Small pupils
  • History of systemic inflammatory disease/uveitis
  • History of psychiatric illness, chronic pain/narcotics, benzodiazepine usage
  • Abnormal liver or renal function

Treatment and study plan

High Intraocular Pressure (IOP)

Other

Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with Intraocular Pressure (IOP) ≤ 24 millimeters of mercury (mmHg) (low IOP) in one eye and with IOP ≥ 65 millimeters of mercury (mmHg) (high IOP) in the other eye.

Low Intraocular Pressure (IOP)

Other

Low Intraocular Pressure (IOP) Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with intraocular IOP ≤ 24 millimeters of mercury (mmHg) (low IOP) in one eye and with IOP ≥ 65 millimeters of mercury (mmHg) (high IOP) in the other eye

Primary outcomes

  1. Medication Rescue

    Time frame: Intraoperative

    Percentage (%) of pts in each group requiring treatment for breakthrough discomfort/pain

Secondary outcomes

  1. Physiologic Responses associated with pain/inflammation:

    Time frame: Intraoperative

    Blood pressure- measured systolic pressure over the diastolic pressure

  2. Physiologic Responses associated with pain/inflammation:

    Time frame: Intraoperative

    Pulse rate- measured in beats per minute (bpm)

  3. Surgeon Experience: Assessment on patient cooperation

    Time frame: Intraoperative

    Surgeon assessment on patient cooperation: poor, good, excellent

    • Poor cooperation: could not follow instructions, lid squeezing, patient had frequent eye & head movements
    • Good cooperation: able to follow directions 50% of the time, some lid squeezing and patient movement
    • Excellent cooperation: able to follow directions >80% of the time with limited lid squeezing and patient movement

  4. Surgeon Experience: Surgeon intraoperative experience

    Time frame: Intraoperative

    Surgeon assessment on overall experience: poor, good, excellent

    • Poor: fluctuating chamber (reverse pupillary block or surge) and reduced efficiency (nucleus & cortex removal)
    • Good: >75% chamber stability and adequate efficiency
    • Excellent: Minimal to no fluctuating chamber and excellent efficiency

  5. Cost- analysis

    Time frame: Intraoperative

    Cost-analysis on intraoperative pharmacological agents utilized between high vs low Intraocular Pressure (IOP)

Sponsors and collaborators

Lead sponsor

Matthew Rauen

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 22, 2024
Registry last updated
May 21, 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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