Clinical trial NCT05495555: The Cutting Efficiency of Hybrid Tips in Different Grades of Cataract
Official title: The Cutting Efficiency of Hybrid Tips in Different Grades of Cataract
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Lead sponsor: Cataract and Laser Institute of Southern Oregon
Sponsor class: OTHER
Collaborators: name: Sengi
First posted: 2022-08-10
Enrollment: 51
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Phaco Time
timeFrame: Day 0 (surgical visit)
measure: Aspiration Time
timeFrame: Day 0 (surgical visit)
measure: Fluid Use
timeFrame: Day 0 (surgical visit)
Secondary outcomes:
measure: Central Corneal Thickness Change From Baseline
timeFrame: baseline and 1 week postoperative
Other outcomes:
measure: Cumulative Dissipated Energy
timeFrame: Day 0 (surgical visit)
Locations:
city: Medford
country: United States
facility: Cataract & Laser Institute
state: Oregon
Study officials:
affiliation: Cataract & Laser Institute
name: Justin Spaulding, DO
role: PRINCIPAL_INVESTIGATOR
References: