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Assess the repeatability and agreement of the Optic Disc Parameters, Retinal Nerve Fiber Layer (RNFL) Thickness, and Full Retinal Thickness between the Maestro and iVue OCT devices
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Eyes | Experimental | Subjects with no known ocular diseases will be scanned with the iVue and Maestro device |
|
| Glaucomatous Eyes | Experimental | Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device |
|
| Eyes with Retinal Diseases | Experimental | Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maestro | Device | OCT machines used for diagnostic purposes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Optic Disc Measurements (Optic Disc Size) | Reporting of the Optic Disc Size difference between the Maestro and iVue | 1 Hour |
| Retinal Nerve Fiber Layer (RNFL) Thickness Measurements | RNFL thickness measured | 1 Hour |
| Full Retinal Thickness Measurement | Full Retinal Thicknesses Measurement | 1 Hour |
| Optic Disc Measurement (Cup Size) | Reporting of the Cup size difference between the Maestro and iVue | 1 Hour |
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Inclusion Criteria for Normal Group
Exclusion Criteria for Normal Group
Inclusion Criteria for Glaucoma Group
Exclusion Criteria for Glaucoma Group
Inclusion Criteria for Retinal Group
Exclusion Criteria for Retinal Group
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| Name | Affiliation | Role |
|---|---|---|
| Mike Sinai, PhD | Topcon Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western University of Health Sciences | Pomona | California | 91716 | United States | ||
| SUNY College of Optometry |
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Eyes | Subjects with no known ocular diseases will be scanned with the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes |
| FG001 | Glaucomatous Eyes | Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes |
| FG002 | Eyes With Retinal Diseases | Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Eyes | Subjects with no known ocular diseases will be scanned with the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes |
| BG001 | Glaucomatous Eyes |
| 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 | Optic Disc Measurements (Optic Disc Size) | Reporting of the Optic Disc Size difference between the Maestro and iVue | Posted | Mean | Standard Deviation | Mircrons squared | 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 | Normal Eyes | Subjects with no known ocular diseases will be scanned with the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines 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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| iVue | Device | OCT machines used for diagnostic purposes |
|
| New York |
| New York |
| 10036 |
| United States |
Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes
| BG002 | Eyes With Retinal Diseases | Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Optic Disc Area Difference | Mean | Standard Deviation | Microns Squared |
|
| OG002 |
| Eyes With Retinal Diseases |
Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes |
|
|
| Primary | Retinal Nerve Fiber Layer (RNFL) Thickness Measurements | RNFL thickness measured | Posted | Mean | Standard Deviation | Microns | 1 Hour |
|
|
|
| Primary | Full Retinal Thickness Measurement | Full Retinal Thicknesses Measurement | Glaucomatous eyes were not scanned and analyzed in the Full Retina Thickness portion of the study. Since the imaging is done in a different area of the eye compare to Retinal Nerve Fiber Layer participants analyzed will be different between these measurement areas. | Posted | Mean | Standard Deviation | Microns | 1 Hour |
|
|
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| Primary | Optic Disc Measurement (Cup Size) | Reporting of the Cup size difference between the Maestro and iVue | Posted | Mean | Standard Deviation | Microns cubed | 1 Hour |
|
|
|
| 0 |
| 58 |
| 0 |
| 58 |
| EG001 | Glaucomatous Eyes | Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes | 0 | 24 | 0 | 24 |
| EG002 | Eyes With Retinal Diseases | Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device Maestro: OCT machines used for diagnostic purposes iVue: OCT machines used for diagnostic purposes | 0 | 27 | 0 | 27 |
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