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The objective of this study is to validate the TopQ cutoff scores, which have been previously determined.
Scans with a TopQ score below the optimum cut-off should be considered to be poor or unacceptable quality, and scans with a TopQ score above the cut-off should be considered good or acceptable quality. The study will evaluate the predetermined cut-off values by investigating measurement variability of scans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects Presenting With Normal Eyes | Subjects with no known ocular diseases will be scanned on the Maestro device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D OCT-1 Maestro | Device | OCT Machine used for diagnostic purposes |
|
| Measure | Description | Time Frame |
|---|---|---|
| TopQ Cut Off | To validate the values of the predetermined TopQ score by showing the variability above and below the TopQ score of 25 for 12x9 Wide, 28 for 6x6 Macula, and 30 for 6x6 Disc scans. | 1 hour |
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Inclusion Criteria
Exclusion Criteria
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Subjects with no known eye disease
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| Name | Affiliation | Role |
|---|---|---|
| Randy Sun, MD | Topcon Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Topcon Medical Systems, Inc. | Oakland | New Jersey | 07436 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Presenting With Normal Eyes | Subjects with no known ocular diseases will be scanned on the Maestro device 3D OCT-1 Maestro: OCT Machine used for diagnostic purposes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Normal healthy eyes without any known eye conditions
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Presenting With Normal Eyes | Subjects with no known ocular diseases will be scanned on the Maestro device 3D OCT-1 Maestro: OCT Machine used for diagnostic purposes |
| 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 | TopQ Cut Off | To validate the values of the predetermined TopQ score by showing the variability above and below the TopQ score of 25 for 12x9 Wide, 28 for 6x6 Macula, and 30 for 6x6 Disc scans. | use of 12 subjects for 3 different scan patterns | Posted | Number | microns | 1 hour |
|
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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 | Subjects Presenting With Normal Eyes | Subjects with no known ocular diseases will be scanned on the Maestro device 3D OCT-1 Maestro: OCT Machine used for diagnostic purposes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles Reisman | Topcon | 201-599-5283 | CREISMAN@topcon.com |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
TopQ of 6x6 Disc Scan
|
|
| 0 |
| 12 |
| 0 |
| 12 |
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