Cataract
Conditions
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.
Interventions
DEVICEINTREPID® Hybrid tip
INTREPID® Hybrid tip for cataract removal
Sponsors
Sengi
Cataract and Laser Institute of Southern Oregon
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phaco Time | Day 0 (surgical visit) |
| Aspiration Time | Day 0 (surgical visit) |
| Fluid Use | Day 0 (surgical visit) |
Secondary
| Measure | Time frame |
|---|---|
| Central Corneal Thickness Change From Baseline | baseline and 1 week postoperative |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Dissipated Energy | Day 0 (surgical visit) | This will measure the the amount of ultrasound energy used during cataract removal |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants. | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Continuous | 75.8 years STANDARD_DEVIATION 6.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 51 participants | — |
| Sex: Female, Male Female | 31 Participants | — |
| Sex: Female, Male Male | 20 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 51 |
| other Total, other adverse events | 3 / 51 | 3 / 51 |
| serious Total, serious adverse events | 0 / 51 | 0 / 51 |
Outcome results
Primary
Aspiration Time
Time frame: Day 0 (surgical visit)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High IOP Setting | Aspiration Time | 101.7 seconds | Standard Deviation 27.2 |
| Low IOP Setting | Aspiration Time | 106.7 seconds | Standard Deviation 25.3 |
Primary
Fluid Use
Time frame: Day 0 (surgical visit)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High IOP Setting | Fluid Use | 41.6 mL | Standard Deviation 9 |
| Low IOP Setting | Fluid Use | 40.2 mL | Standard Deviation 7.8 |
Primary
Phaco Time
Time frame: Day 0 (surgical visit)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High IOP Setting | Phaco Time | 41.6 seconds | Standard Deviation 10 |
| Low IOP Setting | Phaco Time | 41.8 seconds | Standard Deviation 10.2 |
Secondary
Central Corneal Thickness Change From Baseline
Time frame: baseline and 1 week postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High IOP Setting | Central Corneal Thickness Change From Baseline | 5.4 µm | Standard Deviation 5.1 |
| Low IOP Setting | Central Corneal Thickness Change From Baseline | 8.1 µm | Standard Deviation 8.9 |
Other Pre-specified
Cumulative Dissipated Energy
This will measure the the amount of ultrasound energy used during cataract removal
Time frame: Day 0 (surgical visit)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High IOP Setting | Cumulative Dissipated Energy | 8.7 µJ | Standard Deviation 3.1 |
| Low IOP Setting | Cumulative Dissipated Energy | 8.6 µJ | Standard Deviation 3.4 |