Measurement of Anterior Chamber Cell Grading Using Ocular Coherence Tomography

• Sponsor: Rutgers, The State University of New Jersey (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02907814
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arms: 2
• Duration (Months): 19
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Uveitis	Device: Optical Coherence Tomography (OCT); Other: Eye Exam	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• 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
• Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Apr 1, 2018
• Actual Study Completion Date: Apr 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Identified Inflammatory Cells on OCT Scan [Through study completion, up to 1 year.]

   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

1. Change in Cell Density Identified by OCT Scans Over Time [Baseline and up to 8 weeks.]

   Identification of changes in cell density in OCT scans over time

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Doctors Office Center	Newark	New Jersey	United States	07101

Sponsors and Collaborators

• Rutgers, The State University of New Jersey

Investigators

• Principal Investigator: David S Chu, MD, Rutgers University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 24, 2016
• Informed Consent Form - Jul 20, 2016

More Information

Additional Information:

• Laser Safety Information. Laser Institute of America 2016.

Publications

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

• Responsible Party: David S. Chu, MD, Clinical Associate Professor, Rutgers, The State University of New Jersey
• ClinicalTrials.gov Identifier: NCT02907814
• Other Study ID Numbers: Pro20160000585
• First Posted: Sep 20, 2016
• Last Update Posted: May 6, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by David S. Chu, MD, Clinical Associate Professor, Rutgers, The State University of New Jersey: Uveitis; Optical Coherence Tomography
• Additional relevant MeSH terms: Uveitis

Study Results

Participant Flow

Recruitment Details	Ophthalmology clinic, Newark, New Jersey, from 10/26/2016 to 4/1/2018

Arm/Group Title	Uveitis and Cataract Imaging Group	Control
Arm/Group Description	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 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.
Period Title: Overall Study
STARTED	6	0
COMPLETED	0	0
NOT COMPLETED	6	0

Baseline Characteristics

Arm/Group Title	Uveitis and Cataract Imaging Group	Control	Total
Arm/Group Description	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 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.	Total of all reporting groups
Overall Participants	6	0	6
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40 (12.5)	40 (12.5)
Sex: Female, Male (Count of Participants)
Female	4 66.7%	4 Infinity
Male	2 33.3%	2 Infinity
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	6 100%	6 Infinity

Outcome Measures

1. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

Patients with uveitis identified from clinic.

Arm/Group Title	Uveitis and Cataract Imaging Group	Control
Arm/Group Description	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 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.
Measure Participants	6	0
Count of Participants [Participants]	6 100%

2. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

0 of 6 patients had follow up data, unable to identify change over time.

Arm/Group Title	Uveitis and Cataract Imaging Group	Control
Arm/Group Description	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 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.
Measure Participants	0	0

Adverse Events

Time Frame	entire study period, almost 2 years.
Arm/Group Title	Uveitis and Cataract Imaging Group		Control
Arm/Group Description	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 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.
All Cause Mortality
	Uveitis and Cataract Imaging Group		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/0 (NaN)
Serious Adverse Events
	Uveitis and Cataract Imaging Group		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Uveitis and Cataract Imaging Group		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/0 (NaN)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.