Back to resultsSide-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes
Primary Purpose
Retinal Disease, Glaucoma
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
P200TE
Spectral OCT/SLO
Sponsored by
About this trial
This is an interventional other trial for Retinal Disease
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects 18 years of age or older who have full legal capacity to volunteer;
- Subjects who have signed the informed consent;
- Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
- Subjects who agree to participate in the study;
- Subjects with current BSCVA 20/400 or better in the ocular disease study eye(s);
- Subjects diagnosed with ocular disease including but not limited to: Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Central Serous Retinopathy, Macular Hole, Epiretinal Membrane, Macular Edema, Glaucoma, and others in the retinal disease study eye(s) as confirmed at the study visit or within the past six (6) months.
Exclusion Criteria:
- Subjects unable to tolerate ophthalmic imaging;
- Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
- Subjects without ocular disease in study eye(s), as determined by self-report and/or investigator assessment at the study visit;
- Subjects with history of leukemia, dementia or multiple sclerosis.
Sites / Locations
- Medical Center Ophthalmology AssociatesRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
All patients
Arm Description
All patients will be imaged on the P200TE and Spectral OCT/SLO devices.
Outcomes
Primary Outcome Measures
retinal thickness
Retinal Nerve Fibre Layer Thickness
Optic Nerve Head Topography
Cup/Disc Ratio
Secondary Outcome Measures
Full Information
NCT ID
NCT02921568
First Posted
September 16, 2016
Last Updated
March 13, 2017
Sponsor
Optos, PLC
Collaborators
Optos, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02921568
Brief Title
Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes
Official Title
Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Optos, PLC
Collaborators
Optos, Inc.
4. Oversight
5. Study Description
Brief Summary
This study is designed to evaluate and compare in-tissue performance of OCT scans on the new Optos P200TE, versus the predicate Optos Spectral OCT/SLO device.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Disease, Glaucoma
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All patients
Arm Type
Other
Arm Description
All patients will be imaged on the P200TE and Spectral OCT/SLO devices.
Intervention Type
Device
Intervention Name(s)
P200TE
Intervention Description
Optical Coherence Tomography and Scanning Laser Ophthalmoscope device.
Intervention Type
Device
Intervention Name(s)
Spectral OCT/SLO
Intervention Description
Optical Coherence Tomography and Scanning Laser Ophthalmoscope device.
Primary Outcome Measure Information:
Title
retinal thickness
Time Frame
completion of the study, up to 5 years
Title
Retinal Nerve Fibre Layer Thickness
Time Frame
completion of the study, up to 5 years
Title
Optic Nerve Head Topography
Time Frame
completion of the study, up to 5 years
Title
Cup/Disc Ratio
Time Frame
completion of the study, up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subjects 18 years of age or older who have full legal capacity to volunteer;
Subjects who have signed the informed consent;
Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
Subjects who agree to participate in the study;
Subjects with current BSCVA 20/400 or better in the ocular disease study eye(s);
Subjects diagnosed with ocular disease including but not limited to: Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Central Serous Retinopathy, Macular Hole, Epiretinal Membrane, Macular Edema, Glaucoma, and others in the retinal disease study eye(s) as confirmed at the study visit or within the past six (6) months.
Exclusion Criteria:
Subjects unable to tolerate ophthalmic imaging;
Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
Subjects without ocular disease in study eye(s), as determined by self-report and/or investigator assessment at the study visit;
Subjects with history of leukemia, 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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cathy Ellis, BS, MT
Phone
210-697-2036
Ext
2270
Email
cathy@mcoaeyecare.com
First Name & Middle Initial & Last Name & Degree
Michael Singer, MD
First Name & Middle Initial & Last Name & Degree
Darren J Bell, MD
First Name & Middle Initial & Last Name & Degree
James Burns, MD
First Name & Middle Initial & Last Name & Degree
Richard Evans, MD
12. IPD Sharing Statement
Learn more about this trial
Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes
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