Mode
Text Size
Log in / Sign up
N/A Completed N=36

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

Source: ClinicalTrials.gov NCT05868772 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Total Aspiration Time — 90.1; 85.1 seconds

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Total Aspiration Time
90.1; 85.1
SECONDARY
Total Fluid Volume
32.8; 33.8
SECONDARY
Total Phaco Time
29.5; 31.0
SECONDARY
Central Corneal Thickness
554.9; 555.5

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05868772). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

Back to search