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Caffeine is the most widely consumed drinking nutrient in the world. Caffeine effects various organs and the vascular system. It decreases ocular blood flow due to vasoconstriction.
Ingestion of caffeine in glaucoma patients and healthy subjects may decrease peripapillary and macular blood flow in the back of the eye.
The primary objective of this study is to assess the acute changes in peripapillary and macular blood flow before and after an intake of oral caffeine (200 milligram tablet) in glaucoma patients and healthy subjects by using optical coherence tomography angiography (OCTA) scans. This novel imaging tool creates three-dimensional angiograms to assesses signal changes caused by flowing blood cells in a non-invasive angiogram scan. Blood flow is shown as vessel density measured in percentage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glaucoma Patients | Active Comparator | Eligible participants include patients with mild, moderate or advanced primary open angle glaucoma (POAG) or primary angle closure glaucoma (PACG). Each participant will complete baseline study tasks. Each participant will then receive one 200 mg caffeine tablet to ingest. Study tasks will be performed 1 hour and 2 hours after caffeine ingestion. |
|
| Healthy controls | Active Comparator | Eligible participants include healthy subjects with no eye diseases. Each participant will complete baseline study tasks. Each participant will then receive one 200 mg caffeine tablet to ingest. Study tasks will be performed 1 hour and 2 hours after caffeine ingestion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caffeine tablet | Dietary Supplement | Each eligible participant will receive one 200 mg caffeine tablet to ingest after completing all baseline study tasks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood flow change in back of eye before and after caffeine | Optical Coherence Tomography Angiography (OCTA) will be obtained using the Avanti AngioVue High Definition (HD) OCTA by Optovue. Images will include standard 4.5mm HD disc scan, 6mm HD retina scan, regular optic nerve head (ONH) structural scan, 3D-disc baseline scan and a regular ganglion cell complex analysis (GCCA) structural scan. This will measure blood flow changes in the back of the eye by imaging vessel density in percentage before then 1 and 2 hours after caffeine. | Baseline, Hour 1, Hour 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| M. Reza Razeghinejad, MD | Contact | 215-928-7023 | mrazeghi@willseye.org | |
| Jeanne Molineaux, COA | Contact | 215-825-4713 | jmolineaux@gwillseye.org |
| Name | Affiliation | Role |
|---|---|---|
| M. Reza Razeghinejad, MD | Wills Eye Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wills Eye Glaucoma Service | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 25, 2019 | Mar 3, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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All eyes will undergo imaging to measure blood flow in the back of the eye (retina and optic nerve) using the Avanti AngioVue HD OCTA (optical coherence tomography angiography)
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| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |