Measurement of Anterior Chamber Cell Grading Using Ocular Coherence Tomography

Not Applicable

Terminated

• Conditions: Uveitis
• Interventions: Device: Optical Coherence Tomography (OCT); Other: Eye Exam

• Registration Number: NCT02907814
• Lead Sponsor: Rutgers, The State University of New Jersey

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-07
• Study First Submitted QC: 2016-09-15
• Study First Posted: 2016-09-20
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Results First Submitted: 2019-04-10
• Status Verified: 2019-05
• Results First Submitted QC: 2019-05-03
• Last Update Submitted: 2019-05-03
• Results First Posted: 2019-05-06
• Last Update Posted: 2019-05-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uveitis and Cataract Imaging Group	Optical Coherence Tomography (OCT)	Subjects will undergo up to three optical coherence tomography scans.
Control	Eye Exam	Control subjects will undergo a brief, non-contact eye exam and then undergo up to three optical coherence tomography scans.
Control	Optical Coherence Tomography (OCT)	Control subjects will undergo a brief, non-contact eye exam and then undergo up to three optical coherence tomography scans.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Doctors Office Center; 🇺🇸 Newark, New Jersey, United States