Back to resultsNavigated OCT Imaging With the P200TxE
Primary Purpose
Retinal Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Device: P200TxE
Sponsored by
About this trial
This is an interventional device feasibility trial for Retinal Disease
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 presenting with some form of peripheral retina pathology or retina pathology with peripheral manifestations.
Exclusion Criteria:
- Subjects unable to tolerate ophthalmic imaging;
- Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
Sites / Locations
- Retina Consultants of San Diego
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Optical Coherence Tomographer
Arm Description
Outcomes
Primary Outcome Measures
Qualitative Assessment of OCT Clinical Utility
Clinical utility of the OCT scans will be assessed from the clinician questionnaire using a four point scale.
Qualitative Assessment of OCT Scan Quality
Image quality of the OCT scans will be assessed from the clinician questionnaire using a four point scale.
Secondary Outcome Measures
Safety Assessment from Adverse Events
Analysis of safety will be assessed through adverse events reported by the site and documented on each subject's case report form.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04003831
Brief Title
Navigated OCT Imaging With the P200TxE
Official Title
Navigated Peripheral OCT Imaging With the P200TxE
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 13, 2019 (Actual)
Primary Completion Date
December 16, 2020 (Actual)
Study Completion Date
January 18, 2021 (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 P200TxE will be used to obtain peripheral OCT (optical coherence tomography) images.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Disease
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Optical Coherence Tomographer
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Device: 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 Assessment of OCT Clinical Utility
Description
Clinical utility of the OCT scans will be assessed from the clinician questionnaire using a four point scale.
Time Frame
1 year
Title
Qualitative Assessment of OCT Scan Quality
Description
Image quality of the OCT scans will be assessed from the clinician questionnaire using a four point scale.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Safety Assessment from 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.
Time Frame
1 year
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 presenting with some form of peripheral retina pathology or retina pathology with peripheral manifestations.
Exclusion Criteria:
Subjects unable to tolerate ophthalmic imaging;
Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
Facility Information:
Facility Name
Retina Consultants of San Diego
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Navigated OCT Imaging With the P200TxE
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