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The IntraLase iFS femtosecond laser system can create corneal arcuate incisions for cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FS Corneal Incisions | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iFS Femtosecond Laser | Device | corneal incisions created by the femtosecond laser |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions. | Evaluation of incisions created as programmed and measurement in mm. Data reported will be based on intended incision size (as programmed) vs. achieved incision size (as measured). | Day 0, Operative (Within 2 hours of incision creation) |
| Measure | Description | Time Frame |
|---|---|---|
| Surgeon Assessment of Workflow | Surgeon questionnaire (completed at the end of each surgery and the end of each surgical day): Were incisions created as intended? | Day 0, Operative |
| Percent of Seidel Staining |
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Inclusion Criteria:
Exclusion Criteria:
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No preassignment details
Subjects were recruited from private medical practices from October to December 2012
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| ID | Title | Description |
|---|---|---|
| FG000 | FS Corneal Incisions | iFS Femtosecond Laser : corneal incisions created by the femtosecond laser |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FS Corneal Incisions | iFS Femtosecond Laser : corneal incisions created by the femtosecond laser |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions. | Evaluation of incisions created as programmed and measurement in mm. Data reported will be based on intended incision size (as programmed) vs. achieved incision size (as measured). | Posted | Mean | Standard Deviation | mm | Day 0, Operative (Within 2 hours of incision creation) | eyes | eyes |
|
|
The time frame for reporting adverse event reports was 1 month.
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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 | FS Corneal Incisions | iFS Femtosecond Laser : corneal incisions created by the femtosecond laser |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carrie Garufis | AMO | 7145663728 | carrie.garufis@amo.abbott.com |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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Demonstration of no wound leakage as measured by Seidel test at slit lamp with fluorscein dye. A negative Seidel test result indicates no wound leakage.
| Day 0 (performed immediately post-incision creation), Day 1 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| eyes |
|
|
| Secondary | Surgeon Assessment of Workflow | Surgeon questionnaire (completed at the end of each surgery and the end of each surgical day): Were incisions created as intended? | Posted | Number | percentage of yes answers | Day 0, Operative |
|
|
|
| Secondary | Percent of Seidel Staining | Demonstration of no wound leakage as measured by Seidel test at slit lamp with fluorscein dye. A negative Seidel test result indicates no wound leakage. | Posted | Number | percentage of eyes with negative Seidel | Day 0 (performed immediately post-incision creation), Day 1 | eyes | eyes |
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
Clinical Trial Agreement including "Neither Institution nor Principal Investigator shall have any right to publish or present any information or results concerning the Study without express written consent of Sponsor. Under no circumstances shall Institution or Principal Investigator publish or disclose any of Sponsor's proprietary information, as defined by the CDAs, without Sponsor's prior written approval."