What is the Efficiency When Comparing Active Sentry at Low IOP vs Ozil at High IOP?
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Sentry Handpiece At low IOP settings |
Device: Active Sentry Handpiece
With low IOP settings
|
| Ozil Handpiece At high IOP settings |
Device: Ozil Handpiece
With high IOP settings.
|
Outcome Measures
Primary Outcome Measures
- Total aspiration time [Day of surgery (Day 0)]
Secondary Outcome Measures
- Total fluid volume [Day of surgery (Day 0)]
- Total phaco time [Day of surgery (Day 0)]
- Aspiration time during phaco [Day of surgery (Day 0)]
- Central corneal thickness [1 week postoperative]
Other Outcome Measures
- Cumulative dissipated energy [Day of surgery (Day 0)]
The amount of ultrasound energy used to remove a cataractous lens.
Eligibility Criteria
Criteria
Inclusion Criteria:
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
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Be eligible to undergo sequential bilateral uncomplicated cataract surgery.
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Undergo uneventful cataract surgery.
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Gender: Males and Females.
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Both eyes must have same grade of cataract.
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Willing and able to provide written informed consent for participation in the study.
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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.
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Patient under 50 years of age.
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Unable to complete sequential bilateral cataract surgery in both eyes by the same surgeon (JS).
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Patient cataract surgery complicated by posterior capsular tear.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cataract & Laser Institute | Medford | Oregon | United States | 97504 |
Sponsors and Collaborators
- Cataract and Laser Institute of Southern Oregon
- Sengi
Investigators
- Principal Investigator: Justin Spaulding, DO, Cataract and Laser Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JS-23-01