Caffeine Consumption in Glaucoma Patients and Healthy Subjects

Sponsor

Wills Eye (Other)

Overall Status

Recruiting

CT.gov ID

NCT03675412

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Anticipated 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)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 :

Dec 30, 2018

Anticipated Primary Completion Date :

Oct 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).