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| Name | Class |
|---|---|
| Abbott Medical Optics | INDUSTRY |
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This study will measure the dynamic real-time intraocular pressure (IOP) in the anterior chamber during standard phacoemulsification surgery.
What is known:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcon phacoemulsification equipment | Experimental | cataract surgery performed with the Alcon phacoemulsification equipment |
|
| AMO phacoemulsification equipment | Active Comparator | cataract surgery with the AMO phacoemulsification equipment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcon phacoemulsification equipment | Device | cataract surgery with Alcon phacoemulsification equipment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Eyes With Stable IOP | Determine comparative IOP stability between Abbott and Alcon phacoemulsification equipment. | intraoperative |
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Inclusion Criteria:
• Age 18 or greater
Exclusion Criteria:
• Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's heath at risk
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| Name | Affiliation | Role |
|---|---|---|
| Sean McCafferty, MD | Arizona Eye Consultants | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Eye Consultants | Tucson | Arizona | 85710 | United States |
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Patients were included in the study based upon meeting inclusion criteria and not meeting exclusion criteria. Patients were randomized to either group based upon a random number generator.
From September 2016 until December 2016,15 patients were enrolled at Arizona Eye Consultants clinic
| ID | Title | Description |
|---|---|---|
| FG000 | Alcon Phacoemulsification Equipment | cataract surgery performed with the Alcon phacoemulsification equipment Alcon phacoemulsification equipment: cataract surgery with Alcon phacoemulsification equipment. |
| FG001 | AMO Phacoemulsification Equipment | cataract surgery with the AMO phacoemulsification equipment AMO phacoemulsification equipment: cataract surgery with AMO phacoemulsification equipment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
16 eyes from 8 subjects for Alcon equipment and 14 eyes from 7 subjects for AMO.
| ID | Title | Description |
|---|---|---|
| BG000 | Alcon Phacoemulsification Equipment | cataract surgery performed with the Alcon phacoemulsification equipment Alcon phacoemulsification equipment: cataract surgery with Alcon phacoemulsification equipment. |
| BG001 | AMO Phacoemulsification Equipment |
| 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 | Number of Eyes With Stable IOP | Determine comparative IOP stability between Abbott and Alcon phacoemulsification equipment. | Eyes with stable IOP | Posted | Number | Eyes | intraoperative | Eyes | Eyes |
|
4 months
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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 | Alcon Phacoemulsification Equipment | cataract surgery performed with the Alcon phacoemulsification equipment Alcon phacoemulsification equipment: cataract surgery with Alcon phacoemulsification equipment. |
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small population size
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sean McCafferty, MD | Arizona Eye Consultants | (520) 791-7401 | sjmccafferty66@hotmail.com |
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| AMO phacoemulsification equipment | Device | cataract surgery with AMO phacoemulsification equipment. |
|
cataract surgery with the AMO phacoemulsification equipment AMO phacoemulsification equipment: cataract surgery with AMO phacoemulsification equipment. |
| BG002 | Total | Total of all reporting groups |
| Eyes |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants | Participants |
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|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | AMO Phacoemulsification Equipment | cataract surgery with the AMO phacoemulsification equipment AMO phacoemulsification equipment: cataract surgery with AMO phacoemulsification equipment. | 0 | 7 | 0 | 7 | 0 | 7 |
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