The Cutting Efficiency of Hybrid Tips in Different Grades of Cataract

Cataract Clinical Trial

Official title:

The Cutting Efficiency of Hybrid Tips in Different Grades of Cataract

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05495555
• Other study ID #: JS-22-001
• Status: Completed
• Start date: August 3, 2022
• Est. completion date: February 7, 2024

Study information

• Verified date: February 2024
• Source: Cataract and Laser Institute of Southern Oregon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 7, 2024
• Est. primary completion date: February 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• INTREPID® Hybrid tip
INTREPID® Hybrid tip for cataract removal

Locations

Country	Name	City	State
United States	Cataract & Laser Institute	Medford	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Cataract and Laser Institute of Southern Oregon	Sengi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Questionnaire	Visual analog pain scale	1 day postoperative
Other	Cumulative dissipated energy	This will measure the the amount of ultrasound energy used during cataract removal	Day 0 (surgical visit)
Primary	Phaco time		Day 0 (surgical visit)
Primary	Aspiration time		Day 0 (surgical visit)
Primary	Fluid use		Day 0 (surgical visit)
Secondary	Central corneal thickness		1 week postoperative