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

Cataract and Laser Institute of Southern Oregon

Status

Completed

Conditions

Cataract

Treatments

Device: Active Sentry Handpiece

Device: Ozil Handpiece

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05868772

JS-23-01

Details and patient eligibility

About

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

Full 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.

Enrollment

36 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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.