Primary Open Angle Glaucoma
Conditions
Brief summary
High intraocular pressure (IOP) is a known risk factor for developing primary open-angle glaucoma (POAG). There is controversy in the literature regarding the degree to which caffeine influences IOP, with some studies reporting minimal changes in IOP while others report up to 4 mmHg increases. To date there are no double-masked randomized controlled trials that examine acute caffeinated coffee's effects on IOP in patients with or at risk for primary open-angle glaucoma. The investigators aim to better understand the relationship between acute caffeinated coffee (vs decaffeinate coffee) consumption and IOP in a double-masked, crossover randomized controlled clinical trial.
Interventions
OTHERCaffeinated Coffee
Participants will drink one 8 oz cup in the morning hours. Participants have 15 minutes to drink the coffee but may do so in less time.
OTHERDecaffeinated Coffee
Participants will drink one 8 oz cup in the morning hours. Participants have 15 minutes to drink the coffee but may do so in less time.
Sponsors
Massachusetts Eye and Ear Infirmary
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* 40-89 yrs * POAG for cases or no forms of glaucoma for controls * Willingness to drink coffee * Consent signed
Exclusion criteria
* Age less than 40 or greater than 89 yrs * all forms of glaucoma other than POAG * any condition inappropriate for tonometry (ie corneal disease, LASIK) * unable or unwilling to give consent * unable or unwilling to drink coffee * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Intraocular Pressure at 60 Minutes | Prior to coffee ingestion (baseline), 60 minutes post coffee ingestion | At the caffeinated coffee visit: Change in intraocular pressure at 60 minutes = intraocular pressure at 60 minutes post caffeinated coffee ingestion minus intraocular pressure at baseline prior to caffeinated coffee ingestion At the decaffeinated coffee visit: Change in intraocular pressure at 60 minutes = intraocular pressure at 60 minutes post decaffeinated coffee ingestion minus intraocular pressure at baseline prior to decaffeinated coffee ingestion |
| Change in Intraocular Pressure at 90 Minutes | Prior to coffee ingestion (baseline), 90 minutes post coffee ingestion | At the caffeinated coffee visit: Change in intraocular pressure at 90 minutes = intraocular pressure at 90 minutes post caffeinated coffee ingestion minus intraocular pressure at baseline prior to caffeinated coffee ingestion At the decaffeinated coffee visit: Change in intraocular pressure at 90 minutes = intraocular pressure at 90 minutes post decaffeinated coffee ingestion minus intraocular pressure at baseline prior to decaffeinated coffee ingestion |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Who Completed Both Study Visits Only those 106 participants who completed both study visits were included in baseline and final data analyses. The 6 participants who did not complete both study visits were not included in any baseline or final data analyses. | 106 |
| Total | 106 |
Baseline characteristics
| Characteristic | All Participants Who Completed Both Study Visits |
|---|---|
| Age Continuous | 64.4 years STANDARD_DEVIATION 11.7 |
| Baseline Intraocular Pressure on Caffeinated Coffee Visit | 15.90 mmHg STANDARD_DEVIATION 2.78 |
| Baseline Intraocular Pressure on Decaffeinated Coffee Visit | 16.01 mmHg STANDARD_DEVIATION 2.72 |
| Sex: Female, Male Female | 54 Participants |
| Sex: Female, Male Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 108 | 0 / 110 |
| serious Total, serious adverse events | 0 / 108 | 0 / 110 |
Outcome results
Primary
Change in Intraocular Pressure at 60 Minutes
At the caffeinated coffee visit: Change in intraocular pressure at 60 minutes = intraocular pressure at 60 minutes post caffeinated coffee ingestion minus intraocular pressure at baseline prior to caffeinated coffee ingestion At the decaffeinated coffee visit: Change in intraocular pressure at 60 minutes = intraocular pressure at 60 minutes post decaffeinated coffee ingestion minus intraocular pressure at baseline prior to decaffeinated coffee ingestion
Time frame: Prior to coffee ingestion (baseline), 60 minutes post coffee ingestion
Population: Only those 106 participants who completed both study visits were included in baseline and final data analyses. The 6 participants who did not complete both study visits were not included in any baseline or final data analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caffeinated Coffee | Change in Intraocular Pressure at 60 Minutes | 1.51 mm Hg | Standard Deviation 1.54 |
| Decaffeinated Coffee | Change in Intraocular Pressure at 60 Minutes | 0.52 mm Hg | Standard Deviation 1.29 |
Primary
Change in Intraocular Pressure at 90 Minutes
At the caffeinated coffee visit: Change in intraocular pressure at 90 minutes = intraocular pressure at 90 minutes post caffeinated coffee ingestion minus intraocular pressure at baseline prior to caffeinated coffee ingestion At the decaffeinated coffee visit: Change in intraocular pressure at 90 minutes = intraocular pressure at 90 minutes post decaffeinated coffee ingestion minus intraocular pressure at baseline prior to decaffeinated coffee ingestion
Time frame: Prior to coffee ingestion (baseline), 90 minutes post coffee ingestion
Population: Only those 106 participants who completed both study visits were included in baseline and final data analyses. The 6 participants who did not complete both study visits were not included in any baseline or final data analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caffeinated Coffee | Change in Intraocular Pressure at 90 Minutes | 1.46 mm Hg | Standard Deviation 1.68 |
| Decaffeinated Coffee | Change in Intraocular Pressure at 90 Minutes | 0.40 mm Hg | Standard Deviation 1.37 |