Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sengi | INDUSTRY |
Not provided
Not provided
Not provided
The objective is to assess the efficiency of the Active Sentry handpiece at low intraocular pressure (IOP) compared with the Ozil at high IOP.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Sentry Handpiece | At low IOP settings |
| |
| Ozil Handpiece | At high IOP settings |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Sentry Handpiece | Device | With low IOP settings |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Aspiration Time | Day of surgery (Day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Total Fluid Volume | Day of surgery (Day 0) | |
| Total Phaco Time | Day of surgery (Day 0) | |
| Central Corneal Thickness |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day of surgery (Day 0) |
Inclusion Criteria:
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
Exclusion Criteria:
If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
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.
Not provided
Not provided
Not provided
Eligible test subjects will be 50 years of age or older and who are eligible to undergo sequential bilateral uncomplicated cataract surgery.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Justin Spaulding, DO | Cataract and Laser Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cataract & Laser Institute | Medford | Oregon | 97504 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Overall (All Participants) | Contralateral eye study, flow includes all participants. One eye was randomly assigned to either the Active Sentry or Ozil group and the other eye was assigned to the opposite group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall (All Participants) | Contralateral eye study, flow includes all participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Aspiration Time | Posted | Mean | Standard Deviation | seconds | Day of surgery (Day 0) | eyes | eyes |
|
|
1 week
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Sentry Handpiece | With low IOP settings | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| corneal edema | Eye disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Justin Spaulding | Cataract & Laser Institute | 541-779-2020 | justinophtho@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2023 | Mar 4, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Ozil Handpiece |
| Device |
With high IOP settings. |
|
| 1 week postoperative |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| eyes |
|
|
| Secondary | Total Fluid Volume | Posted | Mean | Standard Deviation | mL | Day of surgery (Day 0) | eyes | eyes |
|
|
|
| Secondary | Total Phaco Time | Posted | Mean | Standard Deviation | seconds | Day of surgery (Day 0) | eyes | eyes |
|
|
|
| Secondary | Central Corneal Thickness | Posted | Mean | Standard Deviation | um | 1 week postoperative | eyes | eyes |
|
|
|
| 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. | Posted | Mean | Standard Deviation | unitless | Day of surgery (Day 0) | eyes | eyes |
|
|
|
| 36 |
| 0 |
| 36 |
| 1 |
| 36 |
| EG001 | Ozil Handpiece | With high IOP settings | 0 | 36 | 0 | 36 | 2 | 36 |
| iritis | Eye disorders | Non-systematic Assessment |
|
| Elevated IOP | Eye disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided