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Lack of administrative support
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Optical Coherence Tomography (OCT) is routinely used in ophthalmic clinical practice. It uses infrared light to image patient's eyes. Some patients, such as those with an inflammatory disease called uveitis or those who have just undergone cataract surgery, have intraocular inflammation. This intraocular inflammation commonly manifests as cells that can be seen on routine microscopic clinical examination. However, the only currently available method to quantify this intraocular inflammation is by manually counting on the microscopic clinical examination. The investigators plan to use the OCT machine to image patient's eyes. The investigators will then use the images obtained from the OCT to objectively quantify the degree of intraocular inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uveitis and Cataract Imaging Group | Experimental | Subjects will undergo up to three optical coherence tomography scans. |
|
| Control | Experimental | Control subjects will undergo a brief, non-contact eye exam and then undergo up to three optical coherence tomography scans. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical Coherence Tomography (OCT) | Device | The OCT scan is a brief, non-contact scan of the back of the eye using infrared light. Subjects will see a light and be asked to look forwards while the scan is completed. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Identified Inflammatory Cells on OCT Scan | This measure pertains to the identification of cells in OCT scan of the participants. The inflammatory cells to be identified refer to white blood cells. The anterior segment OCT scan was used to attempt to identify these cells in the anterior chamber of the eyes of the participants. | Through study completion, up to 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cell Density Identified by OCT Scans Over Time | Identification of changes in cell density in OCT scans over time | Baseline and up to 8 weeks. |
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Inclusion Criteria:
Age over 18 years old
Intervention Arm:
Control Arm:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David S Chu, MD | Rutgers University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Doctors Office Center | Newark | New Jersey | 07101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18687418 | Background | Kempen JH, Ganesh SK, Sangwan VS, Rathinam SR. Interobserver agreement in grading activity and site of inflammation in eyes of patients with uveitis. Am J Ophthalmol. 2008 Dec;146(6):813-8.e1. doi: 10.1016/j.ajo.2008.06.004. Epub 2008 Aug 8. | |
| 16196117 | Background | Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep;140(3):509-16. doi: 10.1016/j.ajo.2005.03.057. |
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Ophthalmology clinic, Newark, New Jersey, from 10/26/2016 to 4/1/2018
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| ID | Title | Description |
|---|---|---|
| FG000 | Uveitis and Cataract Imaging Group | Subjects will undergo up to three optical coherence tomography scans. Optical Coherence Tomography (OCT): The OCT scan is a brief, non-contact scan of the back of the eye using infrared light. Subjects will see a light and be asked to look forwards while the scan is completed. |
| FG001 | Control | Control subjects will undergo a brief, non-contact eye exam and then undergo up to three optical coherence tomography scans. Optical Coherence Tomography (OCT): The OCT scan is a brief, non-contact scan of the back of the eye using infrared light. Subjects will see a light and be asked to look forwards while the scan is completed. Eye Exam: This is a brief, non-contact ocular exam. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
6 subjects with uveitis identified in clinic and enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | Uveitis and Cataract Imaging Group | Subjects will undergo up to three optical coherence tomography scans. Optical Coherence Tomography (OCT): The OCT scan is a brief, non-contact scan of the back of the eye using infrared light. Subjects will see a light and be asked to look forwards while the scan is completed. |
| BG001 |
| 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 | Number of Participants With Identified Inflammatory Cells on OCT Scan | This measure pertains to the identification of cells in OCT scan of the participants. The inflammatory cells to be identified refer to white blood cells. The anterior segment OCT scan was used to attempt to identify these cells in the anterior chamber of the eyes of the participants. | Patients with uveitis identified from clinic. | Posted | Count of Participants | Participants | Through study completion, up to 1 year. |
|
entire study period, almost 2 years.
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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 | Uveitis and Cataract Imaging Group | Subjects will undergo up to three optical coherence tomography scans. Optical Coherence Tomography (OCT): The OCT scan is a brief, non-contact scan of the back of the eye using infrared light. Subjects will see a light and be asked to look forwards while the scan is completed. |
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Insufficient enrollment and follow up leading to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elliot Crane | Rutgers New Jersey Medical School | 973-972-2020 | cranees@njms.rutgers.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 | Oct 24, 2016 | Apr 8, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 20, 2016 | Apr 8, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D014605 | Uveitis |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| Eye Exam | Other | This is a brief, non-contact ocular exam. |
|
| Background | User Manual: SPECTRALIS HRA+OCT. Heidelberg Engineering GmbH;2012. |
| 19054493 | Background | Agarwal A, Ashokkumar D, Jacob S, Agarwal A, Saravanan Y. High-speed optical coherence tomography for imaging anterior chamber inflammatory reaction in uveitis: clinical correlation and grading. Am J Ophthalmol. 2009 Mar;147(3):413-416.e3. doi: 10.1016/j.ajo.2008.09.024. Epub 2008 Dec 3. |
| 23249705 | Background | Li Y, Lowder C, Zhang X, Huang D. Anterior chamber cell grading by optical coherence tomography. Invest Ophthalmol Vis Sci. 2013 Jan 9;54(1):258-65. doi: 10.1167/iovs.12-10477. |
| 23945636 | Background | Igbre AO, Rico MC, Garg SJ. High-speed optical coherence tomography as a reliable adjuvant tool to grade ocular anterior chamber inflammation. Retina. 2014 Mar;34(3):504-8. doi: 10.1097/IAE.0b013e31829f73bd. |
| 25846846 | Background | Sharma S, Lowder CY, Vasanji A, Baynes K, Kaiser PK, Srivastava SK. Automated Analysis of Anterior Chamber Inflammation by Spectral-Domain Optical Coherence Tomography. Ophthalmology. 2015 Jul;122(7):1464-70. doi: 10.1016/j.ophtha.2015.02.032. Epub 2015 Apr 4. |
| Control |
Control subjects will undergo a brief, non-contact eye exam and then undergo up to three optical coherence tomography scans. Optical Coherence Tomography (OCT): The OCT scan is a brief, non-contact scan of the back of the eye using infrared light. Subjects will see a light and be asked to look forwards while the scan is completed. Eye Exam: This is a brief, non-contact ocular exam. |
| BG002 | Total | Total of all reporting groups |
| 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 |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Control |
Control subjects will undergo a brief, non-contact eye exam and then undergo up to three optical coherence tomography scans. Optical Coherence Tomography (OCT): The OCT scan is a brief, non-contact scan of the back of the eye using infrared light. Subjects will see a light and be asked to look forwards while the scan is completed. Eye Exam: This is a brief, non-contact ocular exam. |
|
|
| Secondary | Change in Cell Density Identified by OCT Scans Over Time | Identification of changes in cell density in OCT scans over time | 0 of 6 patients had follow up data, unable to identify change over time. | Posted | Baseline and up to 8 weeks. |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Control | Control subjects will undergo a brief, non-contact eye exam and then undergo up to three optical coherence tomography scans. Optical Coherence Tomography (OCT): The OCT scan is a brief, non-contact scan of the back of the eye using infrared light. Subjects will see a light and be asked to look forwards while the scan is completed. Eye Exam: This is a brief, non-contact ocular exam. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |