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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caffeinated Coffee 1st Visit, Decaffeinated Coffee 2nd Visit | Experimental | Participants will be given an 8 oz cup of caffeinated coffee on their first visit and 8 oz cup of decaffeinated coffee on their second visit. |
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| Decaffeinated Coffee 1st Visit, Caffeinated Coffee 2nd Visit | Experimental | Participants will be given an 8 oz cup of decaffeinated coffee on their first visit and 8 oz cup of caffeinated coffee on their second visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caffeinated Coffee | Other | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Prior to coffee ingestion (baseline), 60 minutes post coffee ingestion |
| 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 | Prior to coffee ingestion (baseline), 90 minutes post coffee ingestion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louis R Pasquale, MD | Massachusetts Eye and Ear Infirmary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts Eye and Ear Infirmary | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Caffeinated Coffee 1st Visit, Decaffeinated Coffee 2nd Visit | Participants drank an 8 oz cup of caffeinated coffee on the their first visit, and then an 8 oz cup of decaffeinated coffee on their second visit. The second visit was completed 2 days to 4 weeks after the first visit, depending on the participants' schedules. Participants did not ingest caffeine in any form starting from 12:01am the day of the visit until after the visit that day except for the study coffee we gave to them. |
| FG001 | Decaffeinated Coffee 1st Visit, Caffeinated Coffee 2nd Visit | Participants drank an 8 oz cup of decaffeinated coffee on the their first visit, and then an 8 oz cup of caffeinated coffee on their second visit. The second visit was completed 2 days to 4 weeks after the first visit, depending on the participants' schedules. Participants did not ingest caffeine in any form starting from 12:01am the day of the visit until after the visit that day except for the study coffee we gave to them. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Visit (~1.5-2 Hours) |
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| Time Between Visits (2 Days to 4 Weeks) |
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| Second Visit (~1.5-2 Hours) |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Mean | Standard Deviation | mm Hg | Prior to coffee ingestion (baseline), 60 minutes post coffee ingestion |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Caffeinated Coffee | Participants drank an 8 oz cup of caffeinated coffee. |
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We gave subjects caffeinated coffee on one visit and decaffeinated coffee on the other visit. The changes in outcome parameters we observed (ie IOP changes) could be due to other non-caffeine components in the coffee.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Louis R. Pasquale | Massachusetts Eye and Ear Infirmary | 617-573-4240 | 4240 | aliya_jiwani@meei.harvard.edu |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Decaffeinated Coffee | Other | 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. |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Baseline Intraocular Pressure on Caffeinated Coffee Visit | The intraocular pressure measured at baseline prior to ingestion of caffeinated coffee on the caffeinated coffee visit. | Mean | Standard Deviation | mmHg |
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| Baseline Intraocular Pressure on Decaffeinated Coffee Visit | The intraocular pressure measured at baseline prior to ingestion of decaffeinated coffee on the decaffeinated coffee visit. | Mean | Standard Deviation | mmHg |
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| OG001 | Decaffeinated Coffee | Participants drank an 8 oz cup of decaffeinated coffee. |
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| 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 | 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. | Posted | Mean | Standard Deviation | mm Hg | Prior to coffee ingestion (baseline), 90 minutes post coffee ingestion |
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| 0 |
| 108 |
| 0 |
| 108 |
| EG001 | Decaffeinated Coffee | Participants drank an 8 oz cup of decaffeinated coffee. | 0 | 110 | 0 | 110 |
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