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| ID | Type | Description | Link |
|---|---|---|---|
| 1R44EY034064-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
| Vasoptic Medical, Inc | UNKNOWN |
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The goal of this clinical trial is to investigate the use of an FDA-cleared retinal blood flow imaging instrument called the XyCAM RI and XyCAM FC (Vasoptic Medical, Inc., Columbia, MD) in glaucoma management.
The main question it aims to answer are:
Participants will be
The investigators will capture images of the participant's retina using the XyCAM RI or XyCAM FC ("test data") and by color fundus photography, optical coherence tomography (OCT), and standard automated perimetry (SAP) - the "standard clinical data". The investigators will perform five tests. The first two tests will be conducted using the XyCAM RI or XyCAM FC to obtain "test data". The final two tests will be conducted using routine clinical instruments to obtain "standard clinical data". The investigators will administer eye drops (Tropicamide) to dilate the participant's pupils prior to the first test. Tropicamide is a chemical that causes pupil dilation and is commonly used by doctors to examine the participant's eyes. The entire set of test data sessions should last less than eighty (80) minutes with an additional 60 minutes for carrying out the necessary procedures and imaging using the standard clinical data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | All control participants will be first be imaged pre-intervention. |
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| Glaucoma | Other | All participants with glaucoma will be first be imaged pre-intervention. |
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| Pre-perimetric Glaucoma | Other | All participants with pre-perimetric glaucoma will be first be imaged pre-intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XyCAM with oxygen | Device | After the standard imaging protocols, participants will be asked to inhale 100% oxygen through a mask and will be re-imaged using the XyCAM RI or XyCAM FC. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood flow velocity measure | Dynamic video of ocular blood flow | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Osamah J Saeedi, MD, MS | Contact | (410) 328-5929 | osaeedi@som.umaryland.edu |
| Name | Affiliation | Role |
|---|---|---|
| Grace Forbes, MS | University of Maryland, Baltimore | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Eye Associates at Redwood | Recruiting | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34673279 | Background | Vinnett A, Kandukuri J, Le C, Cho KA, Sinha A, Asanad S, Thompson G, Chen V, Rege A, Saeedi OJ. Dynamic Alterations in Blood Flow in Glaucoma Measured with Laser Speckle Contrast Imaging. Ophthalmol Glaucoma. 2022 May-Jun;5(3):250-261. doi: 10.1016/j.ogla.2021.10.005. Epub 2021 Oct 18. |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
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| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| ID | Term |
|---|---|
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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