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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Active Sentry Handpiece; Device: Ozil Handpiece

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Medford, Oregon, United States, 97504
      • Cataract & Laser Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Eligible test subjects will be 50 years of age or older and who are eligible to undergo sequential bilateral uncomplicated cataract surgery.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Active Sentry Handpiece; At low IOP settings	Device: Active Sentry Handpiece; With low IOP settings
Ozil Handpiece; At high IOP settings	Device: Ozil Handpiece; With high IOP settings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total Aspiration Time	Day of surgery (Day 0)

Secondary Outcome Measures

Outcome Measure	Time Frame
Total Fluid Volume	Day of surgery (Day 0)
Total Phaco Time	Day of surgery (Day 0)
Central Corneal Thickness	1 week postoperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Dissipated Energy (CDE)	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.	Day of surgery (Day 0)

Collaborators and Investigators

• Sponsor: Cataract and Laser Institute of Southern Oregon
• Collaborators: Sengi
• Investigators: Principal Investigator: Justin Spaulding, DO, Cataract and Laser Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2023
• Primary Completion (Actual): April 19, 2024
• Study Completion (Actual): April 19, 2024

Study Registration Dates

• First Submitted: May 3, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: JS-23-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes