- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02001155
Comparing the Effect of the Water Drinking Test on Intraocular Pressure
November 8, 2016 updated by: Jonathon Myers, Wills Eye
Comparing the Effect of the Water Drinking Test on Intraocular Pressure in Patients With Prior Trabeculectomy or Tube Shunt Surgeries
A test that was common in the 1960's and was used to detect primary open angle glaucoma was the water drinking test (patients drank 1 quart of water to stress the fluid drainage mechanism of the eyes.
Intraocular pressure was then measured over the next hour).
Recently this test has been demonstrated as a predictor of peak eye pressure during the day.
The purpose of this study is to compare the results of the water drinking test between eyes that have undergone trabeculectomy and eyes that have undergone tube shunt surgery.
Study Overview
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Wills Eye Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All participants will have open angle glaucoma and have undergone either tube shunt surgery or trabeculectomy.
All participants will be matched for range of recent intraocular pressure (average over the prior three visits of <12 mm Hg, 12 to <18 mm Hg, or >18 mm Hg), as well as number of medications (none, 1-2, 3 or more).
Description
Inclusion Criteria:
- prior trabeculectomy or tube shunt for the treatment of glaucoma
- age 21-90 years
Exclusion Criteria:
- inability to give informed consent
- current ocular infection
- more than 1 prior trabeculectomy, or more than 1 prior tube shunt
- previous refractive surgery
- pregnant women
- heart failure
- renal failure or uncontrolled urine retention
- corneal abnormalities preventing reliable IOP measurement
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Trabeculectomy
Individuals in this group will have undergone a trabeculectomy for the treatment of glaucoma.
|
The Water Drinking test has been identified as a reliable and safe tool to predict maximum intraocular pressure values during a diurnal tension curve and to assess the efficacy of surgical interventions.
Participants are asked to drink 10 ml/kg water (or approximately 0.33 ounces of water for every 2.2 pounds of weight or about 2.5 cups for a 150 lb.
individual) over 15 minutes.
Intraocular pressure is assessed every 15 minutes for one hour.
|
Tube Shunt
Individuals in this group will have undergone a tube shunt for the treatment of glaucoma.
|
The Water Drinking test has been identified as a reliable and safe tool to predict maximum intraocular pressure values during a diurnal tension curve and to assess the efficacy of surgical interventions.
Participants are asked to drink 10 ml/kg water (or approximately 0.33 ounces of water for every 2.2 pounds of weight or about 2.5 cups for a 150 lb.
individual) over 15 minutes.
Intraocular pressure is assessed every 15 minutes for one hour.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intraocular Pressure (IOP)
Time Frame: 1 hour
|
IOP is assessed every 15 minutes for one hour after the water drinking test is complete.
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (ACTUAL)
February 1, 2014
Study Completion (ACTUAL)
July 1, 2014
Study Registration Dates
First Submitted
November 26, 2013
First Submitted That Met QC Criteria
December 3, 2013
First Posted (ESTIMATE)
December 4, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
November 10, 2016
Last Update Submitted That Met QC Criteria
November 8, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WEH - 10-989E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
A manuscript is currently under development.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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