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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05868772
• Other study ID #: JS-23-01
• Status: Completed
• Start date: May 16, 2023
• Est. completion date: April 19, 2024

Study information

• Verified date: April 2024
• Source: Cataract and Laser Institute of Southern Oregon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 19, 2024
• Est. primary completion date: April 19, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Active Sentry Handpiece
With low IOP settings
• Ozil Handpiece
With high IOP settings.

Locations

Country	Name	City	State
United States	Cataract & Laser Institute	Medford	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Cataract and Laser Institute of Southern Oregon	Sengi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cumulative dissipated energy	The amount of ultrasound energy used to remove a cataractous lens.	Day of surgery (Day 0)
Primary	Total aspiration time		Day of surgery (Day 0)
Secondary	Total fluid volume		Day of surgery (Day 0)
Secondary	Total phaco time		Day of surgery (Day 0)
Secondary	Aspiration time during phaco		Day of surgery (Day 0)
Secondary	Central corneal thickness		1 week postoperative