Back to resultsStudy Comparing the P200TE and the P200TxE in Glaucoma Patients
Primary Purpose
Glaucoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
P200TE
P200TxE
Sponsored by
About this trial
This is an interventional diagnostic trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;
- Subjects who can follow the instructions by the clinical staff at the clinical site,
- Subjects who agree to participate in the study;
- Subjects who have been diagnosed with glaucoma in the study eye as confirmed by the investigator;
Exclusion Criteria:
- Subjects unable to tolerate ophthalmic imaging;
- Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
- Subjects with any clinically significant ocular pathology except glaucoma, as determined by self-report and/or investigator assessment on the day of the study visit;
- Subjects who are not reliably tested with at least one Humphrey Field Analyzer (HFA) visual field (24-2 or 30-2, white on white) measured on the day of the study visit or within the previous year from the study visit, defined as fixation losses > 20% or false positives > 33%, or false negatives > 33%;
- Subjects with history of dementia or multiple sclerosis
Sites / Locations
- Medical Center Ophthalmology Associates
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Optical Coherence Tomographer
Arm Description
Outcomes
Primary Outcome Measures
Qualitative B-Scan Assessment
Scores will be based on a 4 point grading scale (0 to 3), with 0 corresponding to failure, 1 is poor, 2 is fair, and 3 is good.
The four point scale is defined as follows:
0 indicates the scan is a failure, and contains no clinically useful information. No relevant structures are visible in the scan.
indicates the condition of the structure or feature being assessed is poor, and it contains very limited clinical utility.
indicates the condition of the structure or feature being assessed is fair or average. It contains some useful clinical information and therefore provides adequate clinical utility.
indicates the condition of the structure or feature being assessed is good. It contains useful clinical information. The clinical utility is high or good.
Secondary Outcome Measures
Number of Participants With Adverse Events
Analysis of safety will be assessed through adverse events reported by the site and documented on each subject's case report form. No AEs were recorded during this study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03912584
Brief Title
Study Comparing the P200TE and the P200TxE in Glaucoma Patients
Official Title
Qualitative OCT Image Grading Study Comparing the P200TE and the P200TxE in Glaucoma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 29, 2019 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Optos, PLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The study evaluates the image quality between two OCT devices.
Detailed Description
The objective of this study is to collect OCT scans to compare the qualitative B scan images produced by the P200TxE to the P200TE device in glaucoma subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Optical Coherence Tomographer
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
P200TE
Intervention Description
The P200TE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.
Intervention Type
Device
Intervention Name(s)
P200TxE
Intervention Description
The P200TxE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.
Primary Outcome Measure Information:
Title
Qualitative B-Scan Assessment
Description
Scores will be based on a 4 point grading scale (0 to 3), with 0 corresponding to failure, 1 is poor, 2 is fair, and 3 is good.
The four point scale is defined as follows:
0 indicates the scan is a failure, and contains no clinically useful information. No relevant structures are visible in the scan.
indicates the condition of the structure or feature being assessed is poor, and it contains very limited clinical utility.
indicates the condition of the structure or feature being assessed is fair or average. It contains some useful clinical information and therefore provides adequate clinical utility.
indicates the condition of the structure or feature being assessed is good. It contains useful clinical information. The clinical utility is high or good.
Time Frame
1 day (start: April 29, 2019 - completed: April 30, 2019)
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
Analysis of safety will be assessed through adverse events reported by the site and documented on each subject's case report form. No AEs were recorded during this study.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;
Subjects who can follow the instructions by the clinical staff at the clinical site,
Subjects who agree to participate in the study;
Subjects who have been diagnosed with glaucoma in the study eye as confirmed by the investigator;
Exclusion Criteria:
Subjects unable to tolerate ophthalmic imaging;
Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
Subjects with any clinically significant ocular pathology except glaucoma, as determined by self-report and/or investigator assessment on the day of the study visit;
Subjects who are not reliably tested with at least one Humphrey Field Analyzer (HFA) visual field (24-2 or 30-2, white on white) measured on the day of the study visit or within the previous year from the study visit, defined as fixation losses > 20% or false positives > 33%, or false negatives > 33%;
Subjects with history of dementia or multiple sclerosis
Facility Information:
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Comparing the P200TE and the P200TxE in Glaucoma Patients
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