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Trial record 15 of 50238 for:    will | Recruiting, Not yet recruiting, Available Studies

Caffeine Consumption in Glaucoma Patients and Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03675412
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
M. Reza Razeghinejad MD, Wills Eye

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glaucoma, Primary Open Angle Dietary Supplement: Caffeine tablet Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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)
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Acute Changes in Optic Nerve Head (ONH) and Macular Blood Flow After Caffeine Consumption in Glaucoma Patients and Healthy Subjects: A Quantitative Optic Coherence Tomography Angiography (OCTA) Study
Actual Study Start Date : December 30, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : January 31, 2020


Arm Intervention/treatment
Active Comparator: 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.
Dietary Supplement: Caffeine tablet
Each eligible participant will receive one 200 mg caffeine tablet to ingest after completing all baseline study tasks.

Active Comparator: 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.
Dietary Supplement: Caffeine tablet
Each eligible participant will receive one 200 mg caffeine tablet to ingest after completing all baseline study tasks.




Primary Outcome Measures :
  1. Blood flow change in back of eye before and after caffeine [ Time Frame: Baseline, Hour 1, Hour 2 ]
    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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 18 to 90 years
  • diagnosis of primary open angle glaucoma (Mild, Moderate and Advanced)
  • healthy subjects with no eye disease

Exclusion Criteria:

  • Diseases, ophthalmic or systemic, that are likely to affect OCTA results
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675412


Contacts
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Contact: M. Reza Razeghinejad, MD 215-928-7023 mrazeghi@willseye.org
Contact: Sheryl S. Wizov, COA 2159283221 swizov@gwillseye.org

Locations
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United States, Pennsylvania
Wills Eye Glaucoma Service Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Judie Tran    215-928-3123    jtran@willseye.org   
Contact: Sheryl S Wizov, COA    215-928-3221    swizov@willseye.org   
Sub-Investigator: Jonathan S Myers, MD         
Sub-Investigator: Jay L Katz, MD         
Sub-Investigator: Marlene R Moster, MD         
Sub-Investigator: Michael J Pro, MD         
Sub-Investigator: Scott Fudemberg, MD         
Sub-Investigator: Anand Montravadi, MD         
Sponsors and Collaborators
Wills Eye
Investigators
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Principal Investigator: M. Reza Razeghinejad, MD Wills Eye Hospital

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Responsible Party: M. Reza Razeghinejad MD, Principal Investigator, Wills Eye
ClinicalTrials.gov Identifier: NCT03675412     History of Changes
Other Study ID Numbers: IRB#18-729
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M. Reza Razeghinejad MD, Wills Eye:
Primary Open Angle Glaucoma (POAG)
Optical Coherence Tomography Angiography (OCTA)
Caffeine
Macular Blood Flow
Peripapillary Blood Flow

Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents