Back to resultsOptic Disc Photograph Collection Study
Primary Purpose
Retina Disease, Glaucoma, Normal
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fundus Camera
Sponsored by
About this trial
This is an interventional diagnostic trial for Retina Disease
Eligibility Criteria
Inclusion Criteria
- Subjects 22 years of age or older on the date of informed consent
- Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
- Subjects met inclusion/exclusion criteria for the OPT1060 protocol
Exclusion Criteria
- Subjects unable to tolerate ophthalmic imaging
- Subjects not able to obtain acceptable OCT, Stereo, or Optomap images due to ocular media opacity or other reasons
Sites / Locations
- Illinois College of OptometryRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Fundus Camera
Arm Description
Outcomes
Primary Outcome Measures
Bland-Altman Plots of Stereo Disc Photos, SLO images and OCT Scans
Deming Regression of Stereo Disc Photos, SLO images and OCT Scans
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05532410
Brief Title
Optic Disc Photograph Collection Study
Official Title
Optic Disc Photograph Collection Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2022 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)
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.
Yes
5. Study Description
Brief Summary
The objective of this study is to collect stereo-optic disc photographs for potential future analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retina Disease, Glaucoma, Normal
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fundus Camera
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Fundus Camera
Intervention Description
The fundus camera is suitable for photographing, displaying and storing data relating to the retina and surrounding parts of the eye. These photographs assist with the diagnosis and follow-up of eye diseases, which can be visually monitored and photographically documented.
Primary Outcome Measure Information:
Title
Bland-Altman Plots of Stereo Disc Photos, SLO images and OCT Scans
Time Frame
1 year
Title
Deming Regression of Stereo Disc Photos, SLO images and OCT Scans
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Subjects 22 years of age or older on the date of informed consent
Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
Subjects met inclusion/exclusion criteria for the OPT1060 protocol
Exclusion Criteria
Subjects unable to tolerate ophthalmic imaging
Subjects not able to obtain acceptable OCT, Stereo, or Optomap images due to ocular media opacity or other reasons
Facility Information:
Facility Name
Illinois College of Optometry
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janely Villa
Phone
312-949-7324
Email
jvilla@ico.edu
First Name & Middle Initial & Last Name & Degree
Michael Chaglasian, OD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Optic Disc Photograph Collection Study
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