The Cutting Efficiency of Hybrid Tips in Different Grades of Cataract

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: INTREPID® Hybrid tip

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.

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Medford, Oregon, United States, 97504
      • Cataract & Laser Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Eligible test subjects will be 50 years of age or older and who are eligible to undergo sequential bilateral uncomplicated cataract surgery.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
High IOP setting; Cataract removal with high IOP setting	Device: INTREPID® Hybrid tip; INTREPID® Hybrid tip for cataract removal
Low IOP setting; Cataract removal with low IOP setting	Device: INTREPID® Hybrid tip; INTREPID® Hybrid tip for cataract removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	Time Frame
Central Corneal Thickness Change From Baseline	baseline and 1 week postoperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Dissipated Energy	This will measure the the amount of ultrasound energy used during cataract removal	Day 0 (surgical visit)

Collaborators and Investigators

• Sponsor: Cataract and Laser Institute of Southern Oregon
• Collaborators: Sengi
• Investigators: Principal Investigator: Justin Spaulding, DO, Cataract & Laser Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2022
• Primary Completion (Actual): February 7, 2024
• Study Completion (Actual): February 7, 2024

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: JS-22-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes