The Cutting Efficiency of Hybrid Tips in Different Grades of Cataract

Study Overview
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Brief Summary
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The objective is to assess the efficiency (as measured by phaco time, aspiration time, and fluid use) of the hybrid tip in removing cataract grade 3 & 4 in high and low intraocular pressure (IOP) settings.

Detailed Description
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This study is a Single site, single-masked, randomized, prospective, observational study of the efficiency of the hybrid tip in removing cataract grade 3 & 4 in high and low intraocular pressure (IOP) settings. Subjects will be assessed pre-operatively, operatively and at 1 day and 1 week post-operatively. Clinical evaluations will include measurement of visual acuity, central corneal thickness, IOP, visual analog pain scale, and slit lamp examination.

Official Title
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The Cutting Efficiency of Hybrid Tips in Different Grades of Cataract

Conditions
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Cataract

Intervention / Treatment
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* Device: INTREPID® Hybrid tip


Participation Criteria
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Eligibility Criteria
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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 Grade 3 or 4 cataract (PNS or LOCS III) Undergo uneventful cataract surgery Gender: Males and Females. Age: 50 or older. 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. 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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High IOP setting<br>Cataract removal with high IOP setting | Device: INTREPID® Hybrid tip<br>* INTREPID® Hybrid tip for cataract removal<br>|
| Low IOP setting<br>Cataract removal with low IOP setting | Device: INTREPID® Hybrid tip<br>* INTREPID® Hybrid tip for cataract removal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phaco time |  | Day 0 (surgical visit) | 
| Aspiration time |  | Day 0 (surgical visit) | 
| Fluid use |  | Day 0 (surgical visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central corneal thickness |  | 1 week postoperative |