Retinal Disease Clinical Trial
Official title:
Navigated Peripheral OCT Imaging With the P200TxE
NCT number | NCT04003831 |
Other study ID # | OPT1033 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 13, 2019 |
Est. completion date | January 18, 2021 |
Verified date | March 2021 |
Source | Optos, PLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The P200TxE will be used to obtain peripheral OCT (optical coherence tomography) images.
Status | Completed |
Enrollment | 26 |
Est. completion date | January 18, 2021 |
Est. primary completion date | December 16, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years and older |
Eligibility | Inclusion Criteria: 1. 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; 2. Subjects who can follow the instructions by the clinical staff at the clinical site, 3. Subjects who agree to participate in the study; 4. Subjects presenting with some form of peripheral retina pathology or retina pathology with peripheral manifestations. Exclusion Criteria: 1. Subjects unable to tolerate ophthalmic imaging; 2. Subjects with ocular media not sufficiently clear to obtain acceptable OCT images; |
Country | Name | City | State |
---|---|---|---|
United States | Retina Consultants of San Diego | Poway | California |
Lead Sponsor | Collaborator |
---|---|
Optos, PLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Qualitative Assessment of OCT Clinical Utility | Clinical utility of the OCT scans will be assessed from the clinician questionnaire using a four point scale. | 1 year | |
Primary | Qualitative Assessment of OCT Scan Quality | Image quality of the OCT scans will be assessed from the clinician questionnaire using a four point scale. | 1 year | |
Secondary | 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. | 1 year |
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