Measurement of Anterior Chamber Cell Grading Using Ocular Coherence Tomography

NCT02907814 | Terminated Results

• 1 other identifier: Pro20160000585
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Uveitis

Keywords

Uveitis; Optical Coherence Tomography

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Change in Cell Density Identified by OCT Scans Over Time

  Baseline and up to 8 weeks.

Study Arms (2)

Uveitis and Cataract Imaging Group

EXPERIMENTAL

Subjects will undergo up to three optical coherence tomography scans.

Device: Optical Coherence Tomography (OCT)

Control

EXPERIMENTAL

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); Other: Eye Exam

Interventions

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.

Control; Uveitis and Cataract Imaging Group

Eye Exam OTHER

This is a brief, non-contact ocular exam.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Doctors Office Center

Newark, New Jersey, 07101, United States

Location

Related Publications (7)

• 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.

  PMID: 18687418 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.

  PMID: 16196117 BACKGROUND

• User Manual: SPECTRALIS HRA+OCT. Heidelberg Engineering GmbH;2012.

  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.

  PMID: 19054493 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.

  PMID: 23249705 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.

  PMID: 23945636 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.

  PMID: 25846846 BACKGROUND

MeSH Terms

Conditions

Uveitis

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Limitations and Caveats

Insufficient enrollment and follow up leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Dr. Elliot Crane
• Organization: Rutgers New Jersey Medical School

cranees@njms.rutgers.edu

973-972-2020

Study Officials

• David S Chu, MD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: September 20, 2016
• Study Start: September 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: May 6, 2019
• Results First Posted: May 6, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)