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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-16

Study Completion Date

2024-04-19

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Active Sentry Handpiece

At low IOP settings

Active Sentry Handpiece

Intervention Type DEVICE

With low IOP settings

Ozil Handpiece

At high IOP settings

Ozil Handpiece

Intervention Type DEVICE

With high IOP settings.

Interventions

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Active Sentry Handpiece

With low IOP settings

Intervention Type DEVICE

Ozil Handpiece

With high IOP settings.

Intervention Type DEVICE

Eligibility Criteria

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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

* 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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes