Caffeine Consumption in Glaucoma Patients and Healthy Subjects

Glaucoma, Primary Open Angle Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03675412
• Other study ID #: IRB#18-729
• Status: Recruiting
• Phase: N/A
• Start date: December 30, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Wills Eye
• Contact: M. Reza Razeghinejad, MD
• Phone: 215-928-7023
• Email: mrazeghi[@]willseye.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Glaucoma, Primary Open Angle

Intervention

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

Locations

Country	Name	City	State
United States	Wills Eye Glaucoma Service	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Wills Eye

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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