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The overall objective is to develop the hardware systems and software algorithms necessary to make accurate measurements of the whole eye with optical coherence tomography (OCT).
The research procedure that each subject will undergo is imaging with the OCT system. Three populations will be included: 1. Normals to ensure the imaging range of the system, 2. Patients with previous LASIK who will be undergoing cataract surgery, and 3. Patients with a history of cataract surgery or high myopia. The third group will also undergo MRI imaging for comparison.
There are no known risks to the subject from imaging with optical coherence tomography beyond what is normal for standard ocular photographic procedures. Light exposure is below ANSI limits. In groups 2 and 3, clinical parameters drawn from the OCT images will be compared to standard of care imaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normals | Experimental | Normal subjects will be imaged with the OCT system to ensure the imaging range of the system. |
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| Patients with a history of cataract surgery or high myopia | Experimental | Subjects will be imaged with both the OCT system and MRI. Reconstructions of the eye from each modality will then be compared. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical Coherence Tomography (OCT) | Device | Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D. The study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Radius of Curvature (Rc) of the Posterior Eye From OCT Compared to MRI | The radius of curvature of the posterior eye will be measured via surface fitting of the posterior eye data from OCT and MRI. Data reported reflects the Rc of the posterior eye measured by OCT minus the value obtained by MRI measurement. | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Duke Eye Center | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Normals | Normal subjects will be imaged with the OCT system to ensure the imaging range of the system. Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D. The study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye. |
| FG001 | Patients With a History of Cataract Surgery or High Myopia | Subjects will be imaged with both the OCT system and MRI. Reconstructions of the eye from each modality will then be compared. Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D. The study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye. Magnetic resonance imaging (MRI): Magnetic resonance imaging (MRI) is a medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in the body. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Normals | Normal subjects will be imaged with the OCT system to ensure the imaging range of the system. Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D. The study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Difference in Radius of Curvature (Rc) of the Posterior Eye From OCT Compared to MRI | The radius of curvature of the posterior eye will be measured via surface fitting of the posterior eye data from OCT and MRI. Data reported reflects the Rc of the posterior eye measured by OCT minus the value obtained by MRI measurement. | Participants who were imaged with both the OCT system and MRI ("Patients with a history of cataract surgery or high myopia" group only). Data not collected on 40 participants. | Posted | Mean | Standard Deviation | mm | 36 months | eyes | eyes |
|
36 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 | Normals | Normal subjects will be imaged with the OCT system to ensure the imaging range of the system. Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D. The study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony Kuo, M.D. | Duke University | 919-684-3799 | anthony.kuo@duke.edu |
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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 | Aug 14, 2014 | Nov 22, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| Magnetic resonance imaging (MRI) | Device | Magnetic resonance imaging (MRI) is a medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in the body. |
|
| BG001 | Patients With a History of Cataract Surgery or High Myopia | Subjects will be imaged with both the OCT system and MRI. Reconstructions of the eye from each modality will then be compared. Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D. The study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye. Magnetic resonance imaging (MRI): Magnetic resonance imaging (MRI) is a medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in the body. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Patients With Previous LASIK Who Will be Undergoing Cataract Surgery | Patients with previous LASIK who will be undergoing cataract surgery subjects will be imaged with the OCT system. Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D. The study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye. |
| OG002 | Patients With a History of Cataract Surgery or High Myopia | Subjects will be imaged with both the OCT system and MRI. Reconstructions of the eye from each modality will then be compared. Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D. The study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye. Magnetic resonance imaging (MRI): Magnetic resonance imaging (MRI) is a medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in the body. |
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| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Patients With a History of Cataract Surgery or High Myopia | Subjects will be imaged with both the OCT system and MRI. Reconstructions of the eye from each modality will then be compared. Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D. The study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye. Magnetic resonance imaging (MRI): Magnetic resonance imaging (MRI) is a medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in the body. | 0 | 64 | 0 | 64 | 0 | 64 |
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| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |