Measurement of Anterior Chamber Cell Grading Using Ocular Coherence Tomography

Uveitis Clinical Trial

Official title:

Objective, Prospective Measurement of Anterior Chamber Cell Grading Using Anterior Chamber Ocular Coherence Tomography

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02907814
• Other study ID #: Pro20160000585
• Status: Terminated
• Phase: N/A
• Start date: September 2016
• Est. completion date: April 2018

Study information

• Verified date: May 2019
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Uveitis

Intervention

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.

Locations

Country	Name	City	State
United States	Doctors Office Center	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Cell Density Identified by OCT Scans Over Time	Identification of changes in cell density in OCT scans over time	Baseline and up to 8 weeks.

External Links

•   Laser Safety Information. Laser Institute of America 2016.