Trial Outcomes & Findings for Measurement of Anterior Chamber Cell Grading Using Ocular Coherence Tomography (NCT NCT02907814)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

Through study completion, up to 1 year.

Results posted on

2019-05-06

Participant Flow

Ophthalmology clinic, Newark, New Jersey, from 10/26/2016 to 4/1/2018

Participant milestones

Participant milestones
Measure	Uveitis and Cataract Imaging Group Subjects will undergo up to three optical coherence tomography scans. 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.	Control Control subjects will undergo a brief, non-contact eye exam and then undergo up to three optical coherence tomography scans. 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. Eye Exam: This is a brief, non-contact ocular exam.
Overall Study STARTED	6	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	6	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Uveitis and Cataract Imaging Group n=6 Participants Subjects will undergo up to three optical coherence tomography scans. 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.	Control Control subjects will undergo a brief, non-contact eye exam and then undergo up to three optical coherence tomography scans. 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. Eye Exam: This is a brief, non-contact ocular exam.	Total n=6 Participants Total of all reporting groups
Age, Continuous	40 years STANDARD_DEVIATION 12.5 • n=6 Participants	—	40 years STANDARD_DEVIATION 12.5 • n=6 Participants
Sex: Female, Male Female	4 Participants n=6 Participants	—	4 Participants n=6 Participants
Sex: Female, Male Male	2 Participants n=6 Participants	—	2 Participants n=6 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	6 participants n=6 Participants	—	6 participants n=6 Participants

PRIMARY outcome

Timeframe: Through study completion, up to 1 year.

Population: Patients with uveitis identified from clinic.

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.

Outcome measures

Outcome measures
Measure	Uveitis and Cataract Imaging Group n=6 Participants Subjects will undergo up to three optical coherence tomography scans. 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.	Control Control subjects will undergo a brief, non-contact eye exam and then undergo up to three optical coherence tomography scans. 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. Eye Exam: This is a brief, non-contact ocular exam.
Number of Participants With Identified Inflammatory Cells on OCT Scan	6 Participants	—

SECONDARY outcome

Timeframe: Baseline and up to 8 weeks.

Population: 0 of 6 patients had follow up data, unable to identify change over time.

Identification of changes in cell density in OCT scans over time

Outcome measures

Outcome data not reported

Adverse Events

Uveitis and Cataract Imaging Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Elliot Crane

Rutgers New Jersey Medical School

Phone: 973-972-2020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place