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Measurement of Anterior Chamber Cell Grading Using Ocular Coherence Tomography

This study is currently recruiting participants.
Verified March 2017 by Rutgers, The State University of New Jersey
Sponsor:
ClinicalTrials.gov Identifier:
NCT02907814
First Posted: September 20, 2016
Last Update Posted: March 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
  Purpose
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.

Condition Intervention
Uveitis Device: Optical Coherence Tomography (OCT) Other: Eye Exam

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Objective, Prospective Measurement of Anterior Chamber Cell Grading Using Anterior Chamber Ocular Coherence Tomography

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Identification of inflammatory cells on OCT scan [ Time Frame: Through study completion, up to 1 year. ]
    Identification of cells in OCT scan


Secondary Outcome Measures:
  • Change in cell density identified by OCT scans over time [ Time Frame: Baseline and up to 8 weeks. ]
    Identification of changes in cell density in OCT scans over time


Estimated Enrollment: 50
Study Start Date: September 2016
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Uveitis and Cataract Imaging Group
Subjects will undergo up to three optical coherence tomography scans.
Device: 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.
Experimental: Control
Control subjects will undergo a brief, non-contact eye exam and then undergo up to three optical coherence tomography scans.
Device: 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.
Other: Eye Exam
This is a brief, non-contact ocular exam.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907814


Contacts
Contact: David S Chu, MD 973-972-2064
Contact: Elliot S Crane, BA 973-972-2037

Locations
United States, New Jersey
Doctors Office Center Recruiting
Newark, New Jersey, United States, 07101
Contact: Elliot Crane, BA    973-972-2037    cranees@njms.rutgers.edu   
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
Principal Investigator: David S Chu, MD Rutgers New Jersey Medical School
  More Information

Additional Information:
Publications:
User Manual: SPECTRALIS HRA+OCT. Heidelberg Engineering GmbH;2012.

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT02907814     History of Changes
Other Study ID Numbers: Pro20160000585
First Submitted: September 7, 2016
First Posted: September 20, 2016
Last Update Posted: March 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rutgers, The State University of New Jersey:
Uveitis
Optical Coherence Tomography

Additional relevant MeSH terms:
Uveitis
Uveal Diseases
Eye Diseases