Caffeine Consumption in Glaucoma Patients and Healthy Subjects

Not Applicable

Recruiting

• Conditions: Glaucoma, Primary Open Angle
• Interventions: Dietary Supplement: Caffeine tablet

• Registration Number: NCT03675412
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-09-05
• Study First Submitted QC: 2018-09-14
• Study First Posted: 2018-09-18
• Study Start: 2018-12-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-26
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glaucoma Patients	Caffeine tablet	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	Caffeine tablet	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.

Primary Outcome Measures

Name	Time	Method
Blood flow change in back of eye before and after caffeine	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.

Trial Locations

Locations (1)

Wills Eye Glaucoma Service; 🇺🇸 Philadelphia, Pennsylvania, United States