The Cutting Efficiency of Hybrid Tips in Different Grades of Cataract
Completed
- Conditions
- Cataract
- Interventions
- Device: INTREPID® Hybrid tip
- Registration Number
- NCT05495555
- Lead Sponsor
- Cataract and Laser Institute of Southern Oregon
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description High IOP setting INTREPID® Hybrid tip Cataract removal with high IOP setting Low IOP setting INTREPID® Hybrid tip Cataract removal with low IOP setting
- Primary Outcome Measures
Name Time Method Phaco Time Day 0 (surgical visit) Aspiration Time Day 0 (surgical visit) Fluid Use Day 0 (surgical visit)
- Secondary Outcome Measures
Name Time Method Central Corneal Thickness Change From Baseline baseline and 1 week postoperative
Trial Locations
- Locations (1)
Cataract & Laser Institute
🇺🇸Medford, Oregon, United States