Clinical trial NCT02907814: 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
Overall status: TERMINATED
Phase: NA
Conditions: Uveitis
Keywords: Uveitis
Optical Coherence Tomography
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Number of Participants With Identified Inflammatory Cells on OCT Scan
timeFrame: Through study completion, up to 1 year.
Secondary outcomes:
measure: Change in Cell Density Identified by OCT Scans Over Time
timeFrame: Baseline and up to 8 weeks.
Other outcomes:
Locations:
city: Newark
country: United States
facility: Doctors Office Center
state: New Jersey
Study officials:
affiliation: Rutgers University
name: David S Chu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: User Manual: SPECTRALIS HRA+OCT. Heidelberg Engineering GmbH;2012.
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.
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.
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.
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.