Caffeine Consumption in Glaucoma Patients and Healthy Subjects

NCT03675412 | Recruiting

• 1 other identifier: IRB#18-729
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma, Primary Open Angle

Keywords

Primary Open Angle Glaucoma (POAG); Optical Coherence Tomography Angiography (OCTA); Caffeine; Macular Blood Flow; Peripapillary Blood Flow

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Dietary Supplement: Caffeine tablet

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.

Dietary Supplement: Caffeine tablet

Interventions

Caffeine tablet DIETARY_SUPPLEMENT

Each eligible participant will receive one 200 mg caffeine tablet to ingest after completing all baseline study tasks.

Glaucoma Patients; Healthy controls

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Wills Eye: lead

Study Sites (1)

Wills Eye Glaucoma Service

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• M. Reza Razeghinejad, MD

  Wills Eye Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

M. Reza Razeghinejad, MD

CONTACT

215-928-7023; mrazeghi@willseye.org

Jeanne Molineaux, COA

CONTACT

215-825-4713; jmolineaux@gwillseye.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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)

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 18, 2018
• Study Start: December 30, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)