NCT05868772CompletedNot Applicable
What is the Efficiency When Comparing Active Sentry at Low IOP vs Ozil at High IOP?
Cataract and Laser Institute of Southern Oregon1 site in 1 country36 target enrollmentStarted: May 16, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Total Aspiration Time
Study Overview
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.
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Total Aspiration Time
Time Frame: Day of surgery (Day 0)
Secondary Outcomes
- Central Corneal Thickness(1 week postoperative)
- Total Fluid Volume(Day of surgery (Day 0))
- Total Phaco Time(Day of surgery (Day 0))
Investigators
Study Sites (1)
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