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

NCT05868772 | Completed Results FDA Device

• 1 other identifier: JS-23-01
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Total Aspiration Time

  Day of surgery (Day 0)

Secondary Outcomes (3)

• Total Fluid Volume

  Day of surgery (Day 0)

• Total Phaco Time

  Day of surgery (Day 0)

• Central Corneal Thickness

  1 week postoperative

Other Outcomes (1)

• Cumulative Dissipated Energy (CDE)

  Day of surgery (Day 0)

Study Arms (2)

Active Sentry Handpiece

At low IOP settings

Device: Active Sentry Handpiece

Ozil Handpiece

At high IOP settings

Device: Ozil Handpiece

Interventions

Active Sentry Handpiece DEVICE

With low IOP settings

Active Sentry Handpiece

Ozil Handpiece DEVICE

With high IOP settings.

Ozil Handpiece

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cataract and Laser Institute of Southern Oregon: lead
• Sengi: collaborator

Study Sites (1)

Cataract & Laser Institute

Medford, Oregon, 97504, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Dr Justin Spaulding
• Organization: Cataract & Laser Institute

justinophtho@gmail.com

541-779-2020

Study Officials

• Justin Spaulding, DO

  Cataract and Laser Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 22, 2023
• Study Start: May 16, 2023
• Primary Completion: April 19, 2024
• Study Completion: April 19, 2024
• Last Updated: April 17, 2025
• Results First Posted: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)