Measurement of Anterior Chamber Cell Grading Using Ocular Coherence Tomography

NCT ID: NCT02907814

Last Updated: 2019-05-06

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Uveitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Uveitis and Cataract Imaging Group

Subjects will undergo up to three optical coherence tomography scans.

Group Type EXPERIMENTAL

Optical Coherence Tomography (OCT)

Intervention Type 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

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

Group Type EXPERIMENTAL

Optical Coherence Tomography (OCT)

Intervention Type 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.

Eye Exam

Intervention Type OTHER

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.

Intervention Type DEVICE

Eye Exam

This is a brief, non-contact ocular exam.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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David S. Chu, MD

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 18687418 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16196117 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 19054493 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23249705 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23945636 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25846846 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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Pro20160000585

Identifier Type: -

Identifier Source: org_study_id

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