Measurement of Anterior Chamber Cell Grading Using Ocular Coherence Tomography
NCT ID: NCT02907814
Last Updated: 2019-05-06
Study Results
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View full resultsBasic Information
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TERMINATED
NA
6 participants
INTERVENTIONAL
2016-09-30
2018-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Intervention Arm:
* Active anterior chamber inflammation in at least one eye as diagnosed by clinical exam
* One of the following: 1) diagnosis of uveitis OR 2) undergone cataract extraction surgery within the previous 30 days
* Control Arm:
* No active intraocular inflammation based on clinical exam
Exclusion Criteria
* Anyone judged unable to understand or consent to study participation
18 Years
ALL
Yes
Sponsors
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Rutgers, The State University of New Jersey
OTHER
Responsible Party
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David S. Chu, MD
Clinical Associate Professor
Principal Investigators
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David S Chu, MD
Role: PRINCIPAL_INVESTIGATOR
Rutgers University
Locations
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Doctors Office Center
Newark, New Jersey, United States
Countries
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References
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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.
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.
User Manual: SPECTRALIS HRA+OCT. Heidelberg Engineering GmbH;2012.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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Pro20160000585
Identifier Type: -
Identifier Source: org_study_id
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