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| Name | Class |
|---|---|
| Sengi | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High IOP setting | Cataract removal with high IOP setting |
| |
| Low IOP setting | Cataract removal with low IOP setting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INTREPID® Hybrid tip | Device | INTREPID® Hybrid tip for cataract removal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phaco Time | Day 0 (surgical visit) | |
| Aspiration Time | Day 0 (surgical visit) | |
| Fluid Use | Day 0 (surgical visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Central Corneal Thickness Change From Baseline | baseline and 1 week postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Dissipated Energy | This will measure the the amount of ultrasound energy used during cataract removal | Day 0 (surgical visit) |
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
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.
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Eligible test subjects will be 50 years of age or older and who are eligible to undergo sequential bilateral uncomplicated cataract surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Justin Spaulding, DO | Cataract & Laser Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cataract & Laser Institute | Medford | Oregon | 97504 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | High IOP Setting | Cataract removal with high IOP setting INTREPID® Hybrid tip: INTREPID® Hybrid tip for cataract removal |
| FG001 | Low IOP Setting | Cataract removal with low IOP setting INTREPID® Hybrid tip: INTREPID® Hybrid tip for cataract removal |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | 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 | Phaco Time | Posted | Mean | Standard Deviation | seconds | Day 0 (surgical visit) | Eyes | Eyes |
|
|
1 week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High IOP Setting | Cataract removal with high IOP setting INTREPID® Hybrid tip: INTREPID® Hybrid tip for cataract removal |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated IOP | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Justin Spaulding | Cataract & Laser Institute | 541-779-2020 | justinophtho@gmail.com |
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| 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 | Feb 21, 2023 | Jan 15, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| 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 |
|
| Region of Enrollment | Number | participants |
|
|
| Eyes |
|
|
| Primary | Aspiration Time | Posted | Mean | Standard Deviation | seconds | Day 0 (surgical visit) | Eyes | Eyes |
|
|
|
| Primary | Fluid Use | Posted | Mean | Standard Deviation | mL | Day 0 (surgical visit) | Eyes | Eyes |
|
|
|
| Secondary | Central Corneal Thickness Change From Baseline | Posted | Mean | Standard Deviation | µm | baseline and 1 week postoperative | Eyes | Eyes |
|
|
|
| Other Pre-specified | Cumulative Dissipated Energy | This will measure the the amount of ultrasound energy used during cataract removal | Posted | Mean | Standard Deviation | µJ | Day 0 (surgical visit) | Eyes | Eyes |
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| 3 |
| 51 |
| EG001 | Low IOP Setting | Cataract removal with low IOP setting INTREPID® Hybrid tip: INTREPID® Hybrid tip for cataract removal | 0 | 51 | 0 | 51 | 3 | 51 |
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