Clinical trial NCT05868772: What is the Efficiency When Comparing Active Sentry at Low IOP vs Ozil at High IOP?
Official title: What is the Efficiency When Comparing Active Sentry at Low IOP vs Ozil at High IOP?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Lead sponsor: Cataract and Laser Institute of Southern Oregon
Sponsor class: OTHER
Collaborators: name: Sengi
First posted: 2023-05-22
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total Aspiration Time
timeFrame: Day of surgery (Day 0)
Secondary outcomes:
measure: Total Fluid Volume
timeFrame: Day of surgery (Day 0)
measure: Total Phaco Time
timeFrame: Day of surgery (Day 0)
measure: Central Corneal Thickness
timeFrame: 1 week postoperative
Other outcomes:
measure: Cumulative Dissipated Energy (CDE)
timeFrame: Day of surgery (Day 0)
Locations:
city: Medford
country: United States
facility: Cataract & Laser Institute
state: Oregon
Study officials:
affiliation: Cataract and Laser Institute
name: Justin Spaulding, DO
role: PRINCIPAL_INVESTIGATOR
References: