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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02907814
Other study ID # Pro20160000585
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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