Caffeine Consumption in Glaucoma Patients and Healthy Subjects

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

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.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma, Primary Open Angle
• Intervention / Treatment: Dietary supplement: Caffeine tablet

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: M. Reza Razeghinejad, MD; Phone Number: 215-928-7023; Email: mrazeghi@willseye.org
• Study Contact Backup: Name: Jeanne Molineaux, COA; Phone Number: 215-825-4713; Email: jmolineaux@gwillseye.org

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Wills Eye Glaucoma Service
      • Contact: Jeanne Molineaux, COA; Phone Number: 215-825-4713; Email: jmolineaux@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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Wills Eye
• Investigators: Principal Investigator: M. Reza Razeghinejad, MD, Wills Eye Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2018
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: September 5, 2018
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (Actual): September 18, 2018

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Caffeine; Primary Open Angle Glaucoma (POAG); Optical Coherence Tomography Angiography (OCTA); Macular Blood Flow; Peripapillary Blood Flow
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Caffeine
• Other Study ID Numbers: IRB#18-729

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No