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Collect OCT data to evaluate the range and age trend of ocular measurements.
This is a prospective, multi-center study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. Subjects qualified to continue will undergo imaging of both eyes using the SPECTRALIS OCT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normals | No eye disease. |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoints | The primary endpoints are the structural measurement values of (1) the ONH, (2) the peri-papillary RNFL, and (3) the macula obtained using the Spectralis OCT and the statistical descriptors such as mean, standard deviation, and distribution percentiles. | 3 months |
| Bruch's Membrane Opening - Minimum Rim Area, Global | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
Unreliable visual field. The reliability indices should be used as guide as well as the perimetrist's notes.
Unusable disc stereo photos.
Inability to undergo the tests.
Insufficient quality of Spectralis OCT images (this is not determined until after Spectralis OCT examination, and is an unusual circumstance). Minimum requirements are:
Note: Inability of a subject to perform one of the two scan patterns or insufficient image quality in one scan pattern does not exclude the subject or eye from the study.
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No eye disease.
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| Name | Affiliation | Role |
|---|---|---|
| Balwantray Chauhan, PhD | Dalhousie University, Halifax, NS, Canada | Principal Investigator |
| Claude Burgoyne, MD | Devers Eye Institute, Portland, OR, USA | Principal Investigator |
| Christopher Girkin, MD | Callahan Eye Foundation Hospital, Birmingham, AL, USA | Principal Investigator |
| Christian Mardin, MD | Augenklinik des Universitätsklinikums Erlangen, Erlangen, Germany | Principal Investigator |
| Alexander Scheuerle, MD | Universitätsaugenklinik, Heidelberg, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dalhousie University | Halifax | Nova Scotia | B3H 2Y9 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Normals | No eye disease. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Normals | No eye disease. |
| 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 | Primary Endpoints | The primary endpoints are the structural measurement values of (1) the ONH, (2) the peri-papillary RNFL, and (3) the macula obtained using the Spectralis OCT and the statistical descriptors such as mean, standard deviation, and distribution percentiles. | Posted | Mean | Standard Deviation | microns | 3 months |
|
|
1 year
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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 | Normals | No adverse events were reported. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerhard Zinser, PhD | Heidelberg Engineering GmbH | +4962216463 | 0 | Contact@HeidelbergEngineering.com |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Participants |
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| Gender | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Subjects of Caucasian descent | Number | participants |
|
|
|
| Primary | Bruch's Membrane Opening - Minimum Rim Area, Global | Posted | Mean | Standard Deviation | microns^2 | 3 months |
|
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| 0 |
| 303 |
| 0 |
| 303 |
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