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OpenTrials
Completed

NCT Number: NCT05868772

What is the Efficiency When Comparing Active Sentry at Low IOP vs Ozil at High IOP?

The objective is to assess the efficiency of the Active Sentry handpiece at low intraocular pressure (IOP) compared with the Ozil at high IOP.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cataract & Laser Institute

Medford, Oregon, 97504, United States

About this study

This study is a single site, single-masked, randomized, prospective, contralateral eye study of the efficiency of the Active Sentry handpiece at low IOP compared with the Ozil at high IOP.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

  • Be eligible to undergo sequential bilateral uncomplicated cataract surgery.
  • Undergo uneventful cataract surgery.
  • Gender: Males and Females.
  • Both eyes must have same grade of cataract.
  • Willing and able to provide written informed consent for participation in the study.
  • Willing and able to comply with scheduled visits and other study procedures.

Exclusion criteria

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

  • Patient under 50 years of age.
  • Unable to complete sequential bilateral cataract surgery in both eyes by the same surgeon (JS).
  • Patient cataract surgery complicated by posterior capsular tear.
  • Any disease state deemed by PI that increases risk of complicated cataract surgery (ie Pseudoexfoliation syndrome, zonular dehiscence, history of eye trauma, RA, prior refractive surgery, etc).

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Treatment and study plan

Active Sentry Handpiece

Device

With low IOP settings

Ozil Handpiece

Device

With high IOP settings.

Primary outcomes

  1. Total Aspiration Time

    Time frame: Day of surgery (Day 0)

Secondary outcomes

  1. Total Fluid Volume

    Time frame: Day of surgery (Day 0)

  2. Total Phaco Time

    Time frame: Day of surgery (Day 0)

  3. Central Corneal Thickness

    Time frame: 1 week postoperative

Other outcomes

  1. Cumulative Dissipated Energy (CDE)

    Time frame: Day of surgery (Day 0)

    CDE is the amount of ultrasound energy used to remove a cataractous lens. CDE is the power and time of torsional and longitudinal ultrasound delivery modes. It is not expressed in standard units, but is generally unitless. CDE is calculated by the Centurion® Vision System automatically. A lower value is indicative of lower energy used in the eye.

Sponsors and collaborators

Lead sponsor

Cataract and Laser Institute of Southern Oregon

Other

Collaborators

  • Sengi

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 22, 2023
Registry last updated
Apr 17, 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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