Cataract
Conditions
Brief summary
The objective is to assess the efficiency of the Active Sentry handpiece at low intraocular pressure (IOP) compared with the Ozil at high IOP.
Detailed description
This study is a single site, single-masked, randomized, prospective, contralateral eye study of the efficiency of the Active Sentry handpiece at low IOP compared with the Ozil at high IOP.
Interventions
DEVICEActive Sentry Handpiece
With low IOP settings
DEVICEOzil Handpiece
With high IOP settings.
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
Yes
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. * Undergo uneventful cataract surgery. * Gender: Males and Females. * Both eyes must have same grade of cataract. * 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.
Exclusion criteria
If any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Aspiration Time | Day of surgery (Day 0) |
Secondary
| Measure | Time frame |
|---|---|
| Total Fluid Volume | Day of surgery (Day 0) |
| Total Phaco Time | Day of surgery (Day 0) |
| Central Corneal Thickness | 1 week postoperative |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Dissipated Energy (CDE) | Day of surgery (Day 0) | CDE is the amount of ultrasound energy used to remove a cataractous lens. CDE is the power and time of torsional and longitudinal ultrasound delivery modes. It is not expressed in standard units, but is generally unitless. CDE is calculated by the Centurion® Vision System automatically. A lower value is indicative of lower energy used in the eye. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall (All Participants) Contralateral eye study, flow includes all participants | 36 |
| Total | 36 |
Baseline characteristics
| Characteristic | Overall (All Participants) | — |
|---|---|---|
| Age, Continuous | 71.3 years STANDARD_DEVIATION 6.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 19 Participants | — |
| Sex: Female, Male Male | 17 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 36 |
| other Total, other adverse events | 1 / 36 | 2 / 36 |
| serious Total, serious adverse events | 0 / 36 | 0 / 36 |
Outcome results
Primary
Total Aspiration Time
Time frame: Day of surgery (Day 0)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Sentry Handpiece | Total Aspiration Time | 90.1 seconds | Standard Deviation 16.4 |
| Ozil Handpiece | Total Aspiration Time | 85.1 seconds | Standard Deviation 17 |
Secondary
Central Corneal Thickness
Time frame: 1 week postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Sentry Handpiece | Central Corneal Thickness | 554.9 um | Standard Deviation 27.6 |
| Ozil Handpiece | Central Corneal Thickness | 555.5 um | Standard Deviation 28.8 |
Secondary
Total Fluid Volume
Time frame: Day of surgery (Day 0)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Sentry Handpiece | Total Fluid Volume | 32.8 mL | Standard Deviation 4.6 |
| Ozil Handpiece | Total Fluid Volume | 33.8 mL | Standard Deviation 6 |
Secondary
Total Phaco Time
Time frame: Day of surgery (Day 0)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Sentry Handpiece | Total Phaco Time | 29.5 seconds | Standard Deviation 7.3 |
| Ozil Handpiece | Total Phaco Time | 31.0 seconds | Standard Deviation 7.4 |
Other Pre-specified
Cumulative Dissipated Energy (CDE)
CDE is the amount of ultrasound energy used to remove a cataractous lens. CDE is the power and time of torsional and longitudinal ultrasound delivery modes. It is not expressed in standard units, but is generally unitless. CDE is calculated by the Centurion® Vision System automatically. A lower value is indicative of lower energy used in the eye.
Time frame: Day of surgery (Day 0)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Sentry Handpiece | Cumulative Dissipated Energy (CDE) | 5.0 unitless | Standard Deviation 1.9 |
| Ozil Handpiece | Cumulative Dissipated Energy (CDE) | 5.2 unitless | Standard Deviation 1.7 |