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| Name | Class |
|---|---|
| Sengi | INDUSTRY |
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The objective is to evaluate the resultant thickness of the FS200 created LASIK flap compared to plan at the surgical visit.
This study is a Single site, single-arm, prospective, observational study of the accuracy of the intended flap thickness, after successful bilateral LASIK surgery. Subjects will be assessed pre-operatively, operatively and at 1 day post-operatively. Clinical evaluations will include measurement of visual acuity, manifest refraction, and flap thickness, and flap diameter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WaveLight® FS200 femtosecond laser | Flap creation with the WaveLight® FS200 femtosecond laser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WaveLight® FS200 femtosecond laser | Device | Flap creation with the WaveLight® FS200 femtosecond laser |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Resultant Thickness of the FS200 Created LASIK Flap Compared to Plan at the Surgical Visit. | 1 day postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| The Resultant Diameter of the FS200 Created LASIK Flap Compared to Plan | 1 day postoperative | |
| Pre-operative Pachymetry as Measured by the EX500 Versus the Oculus Pentacam | Thickness measurements compared between 2 devices: the EX500 and the Oculus Pentacam |
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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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Subjects 18 years of age or older who are interested in and appropriate candidates for LASIK.
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Wexler, MD | Bismarck Lasik | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bismarck Lasik | Bismarck | North Dakota | 58501 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | WaveLight® FS200 Femtosecond Laser | Flap creation with the WaveLight® FS200 femtosecond laser WaveLight® FS200 femtosecond laser: Flap creation with the WaveLight® FS200 femtosecond laser |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | WaveLight® FS200 Femtosecond Laser | Flap creation with the WaveLight® FS200 femtosecond laser WaveLight® FS200 femtosecond laser: Flap creation with the WaveLight® FS200 femtosecond laser |
| 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 | The Resultant Thickness of the FS200 Created LASIK Flap Compared to Plan at the Surgical Visit. | 116 Eyes of 58 participants | Posted | Mean | Standard Deviation | um | 1 day postoperative | Eyes | Eyes |
|
|
2 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 | WaveLight® FS200 Femtosecond Laser | Flap creation with the WaveLight® FS200 femtosecond laser WaveLight® FS200 femtosecond laser: Flap creation with the WaveLight® FS200 femtosecond laser |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Stephen Wexler | Bismarck Lasik | 701-222-2020 | drwexler@bismarcklasik.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 | Sep 19, 2022 | Dec 7, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Day 0 (surgical visit) |
| 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 | The Resultant Diameter of the FS200 Created LASIK Flap Compared to Plan | 116 Eyes of 58 participants | Posted | Mean | Standard Deviation | mm | 1 day postoperative | Eyes | Eyes |
|
|
|
| Secondary | Pre-operative Pachymetry as Measured by the EX500 Versus the Oculus Pentacam | Thickness measurements compared between 2 devices: the EX500 and the Oculus Pentacam | 116 Eyes of 58 participants | Posted | Mean | Standard Deviation | um | Day 0 (surgical visit) | Eyes | Eyes |
|
|
|
|
| 0 |
| 58 |
| 0 |
| 58 |
| 0 |
| 58 |
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