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Measurement of Anterior Chamber Cell Grading Using Ocular Coherence Tomography

Primary Purpose

Uveitis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Optical Coherence Tomography (OCT)
Eye Exam
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Uveitis focused on measuring Uveitis, Optical Coherence Tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age over 18 years old
  • 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:

  • Corneal opacities in the affected eye
  • Anyone judged unable to understand or consent to study participation

Sites / Locations

  • Doctors Office Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Uveitis and Cataract Imaging Group

Control

Arm Description

Subjects will undergo up to three optical coherence tomography scans.

Control subjects will undergo a brief, non-contact eye exam and then undergo up to three optical coherence tomography scans.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Cell Density Identified by OCT Scans Over Time
Identification of changes in cell density in OCT scans over time

Full Information

First Posted
September 7, 2016
Last Updated
May 3, 2019
Sponsor
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT02907814
Brief Title
Measurement of Anterior Chamber Cell Grading Using Ocular Coherence Tomography
Official Title
Objective, Prospective Measurement of Anterior Chamber Cell Grading Using Anterior Chamber Ocular Coherence Tomography
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of administrative support
Study Start Date
September 2016 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis
Keywords
Uveitis, Optical Coherence Tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Uveitis and Cataract Imaging Group
Arm Type
Experimental
Arm Description
Subjects will undergo up to three optical coherence tomography scans.
Arm Title
Control
Arm Type
Experimental
Arm Description
Control subjects will undergo a brief, non-contact eye exam and then undergo up to three optical coherence tomography scans.
Intervention Type
Device
Intervention Name(s)
Optical Coherence Tomography (OCT)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Eye Exam
Intervention Description
This is a brief, non-contact ocular exam.
Primary Outcome Measure Information:
Title
Number of Participants With Identified Inflammatory Cells on OCT Scan
Description
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.
Time Frame
Through study completion, up to 1 year.
Secondary Outcome Measure Information:
Title
Change in Cell Density Identified by OCT Scans Over Time
Description
Identification of changes in cell density in OCT scans over time
Time Frame
Baseline and up to 8 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age over 18 years old 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: Corneal opacities in the affected eye Anyone judged unable to understand or consent to study participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S Chu, MD
Organizational Affiliation
Rutgers University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Doctors Office Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07101
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18687418
Citation
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.
Results Reference
background
PubMed Identifier
16196117
Citation
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.
Results Reference
background
Citation
User Manual: SPECTRALIS HRA+OCT. Heidelberg Engineering GmbH;2012.
Results Reference
background
PubMed Identifier
19054493
Citation
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.
Results Reference
background
PubMed Identifier
23249705
Citation
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.
Results Reference
background
PubMed Identifier
23945636
Citation
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.
Results Reference
background
PubMed Identifier
25846846
Citation
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.
Results Reference
background
Links:
URL
http://www.lia.org/subscriptions/safety_bulletin/laser_safety_information
Description
Laser Safety Information. Laser Institute of America 2016.

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Measurement of Anterior Chamber Cell Grading Using Ocular Coherence Tomography

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