The Cutting Efficiency of Hybrid Tips in Different Grades of Cataract

Cataract and Laser Institute of Southern Oregon

Status

Completed

Conditions

Cataract

Treatments

Device: INTREPID® Hybrid tip

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05495555

JS-22-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

51 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.