Caffeine Consumption in Glaucoma Patients and Healthy Subjects
NCT ID: NCT03675412
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2018-12-30
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Glaucoma Patients
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.
Caffeine tablet
Each eligible participant will receive one 200 mg caffeine tablet to ingest after completing all baseline study tasks.
Healthy controls
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.
Caffeine tablet
Each eligible participant will receive one 200 mg caffeine tablet to ingest after completing all baseline study tasks.
Interventions
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Caffeine tablet
Each eligible participant will receive one 200 mg caffeine tablet to ingest after completing all baseline study tasks.
Eligibility Criteria
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Inclusion Criteria
* diagnosis of primary open angle glaucoma (Mild, Moderate and Advanced)
* healthy subjects with no eye disease
Exclusion Criteria
* greater than moderate cataract
* nystagmus
* inability to look at target
* macular degeneration other than mild drusen or pigmentary changes
* diabetic retinopathy
* neovascular glaucoma or non-glaucoma optic neuropathies
* current macular edema, prior laser to retina, inflammatory retinopathy or choroidopathy
* keratoconus, corneal ectasia, central corneal scarring
* rheumatologic diseases or Raynaud's phenomena
* pregnant and lactating women
* mental illness or alcohol addiction
* pre-existing bladder symptoms, cardiac disease or sleep disorder
* refractive spherical diopter greater than 5 or cylinder greater than 3
* possible tolerance to caffeine (drinking more than 1 cup coffee per day).
18 Years
90 Years
ALL
Yes
Sponsors
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Wills Eye
OTHER
Responsible Party
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M. Reza Razeghinejad MD
Principal Investigator
Principal Investigators
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M. Reza Razeghinejad, MD
Role: PRINCIPAL_INVESTIGATOR
Wills Eye Hospital
Locations
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Wills Eye Glaucoma Service
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Jeanne Molineaux, COA
Role: primary
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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IRB#18-729
Identifier Type: -
Identifier Source: org_study_id