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Caffeine Consumption in Glaucoma Patients and Healthy Subjects

Primary Purpose

Glaucoma, Primary Open Angle

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caffeine tablet
Sponsored by
Wills Eye
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma, Primary Open Angle focused on measuring Primary Open Angle Glaucoma (POAG), Optical Coherence Tomography Angiography (OCTA), Caffeine, Macular Blood Flow, Peripapillary Blood Flow

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Wills Eye Glaucoma ServiceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Glaucoma Patients

Healthy controls

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 5, 2018
Last Updated
May 1, 2023
Sponsor
Wills Eye
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1. Study Identification

Unique Protocol Identification Number
NCT03675412
Brief Title
Caffeine Consumption in Glaucoma Patients and Healthy Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 30, 2018 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wills Eye

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Primary Open Angle
Keywords
Primary Open Angle Glaucoma (POAG), Optical Coherence Tomography Angiography (OCTA), Caffeine, Macular Blood Flow, Peripapillary Blood Flow

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Glaucoma Patients
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Healthy controls
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Caffeine tablet
Intervention Description
Each eligible participant will receive one 200 mg caffeine tablet to ingest after completing all baseline study tasks.
Primary Outcome Measure Information:
Title
Blood flow change in back of eye before and after caffeine
Description
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.
Time Frame
Baseline, Hour 1, Hour 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
M. Reza Razeghinejad, MD
Phone
215-928-7023
Email
mrazeghi@willseye.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jeanne Molineaux, COA
Phone
215-825-4713
Email
jmolineaux@gwillseye.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Reza Razeghinejad, MD
Organizational Affiliation
Wills Eye Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wills Eye Glaucoma Service
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanne Molineaux, COA
Phone
215-825-4713
Email
jmolineaux@willseye.org
First Name & Middle Initial & Last Name & Degree
Jonathan S Myers, MD
First Name & Middle Initial & Last Name & Degree
Jay L Katz, MD
First Name & Middle Initial & Last Name & Degree
Marlene R Moster, MD
First Name & Middle Initial & Last Name & Degree
Michael J Pro, MD
First Name & Middle Initial & Last Name & Degree
Scott Fudemberg, MD
First Name & Middle Initial & Last Name & Degree
Anand Montravadi, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Caffeine Consumption in Glaucoma Patients and Healthy Subjects

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