- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02613533
Water Drinking Test in Patients With Occludable Angle
November 28, 2017 updated by: Jonathon Myers, Wills Eye
What is the Effect of the "Water Drinking Test" on Patients With Narrow Angles on the Day of Their Scheduled Laser Iridotomy?
The water drinking test (WDT), is a predictive test that has been used to detect primary open angle glaucoma and recently has been demonstrated as a predictor of the diurnal tension curve.
Clinically accurate provocative tests for asymptomatic eyes with shallow anterior chambers and narrow angles are highly desirable to detect patients prone to angle closure glaucoma.
The aim of this pilot study is to evaluate the possible role of water drinking test in patients with narrow angles who are scheduled for prophylactic laser iridotomy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This prospective case series will investigate the effects of the WDT on subjects with narrow anterior chamber angles on the day of their scheduled laser iridotomy.
The angle configuration and IOP will be monitored following the WDT.
Twenty patients with occludable angles will be enrolled in this study.
After measuring the baseline IOP, weight and height, the patients will be asked to drink 10ml/kg water over 15 minutes (equal to approximately 0.33 ounces of water for every 2.2 pounds of weight or 2 ½ cups for a 150 lb.
individual) and their IOP will be checked every 15 minutes up to one hour after drinking the water.
This will be repeated after performing a laser iridotomy.
The data obtained, mainly IOP and gonioscopic findings, will be analyzed using statistical tests and compared to historical controls of the WDT without narrow angles, and laser iridotomy subjects without the WDT.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
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
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Wills Eye Institute
-
-
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
19 years to 88 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- narrow angle judged to be at risk of attack by the treating physician, with one or more quadrants not open to the sclera spur on gonioscopy
- age between 21 and 90 years
- ability to give informed consent.
Exclusion Criteria:
- baseline IOP higher than 21 mm Hg with or without medication
- other causes of glaucoma, such as pseudoexfoliative and pigmentary glaucomas
- previous treatment with argon laser or selective laser trabeculoplasty
- previous refractive sugary; (5) pregnant women; (6) congestive heart failure
- renal failure or urinary retention issues; (8) corneal abnormalities preventing reliable IOP measurement
- non-glaucomatous optic neuropathy
- prior refractive surgery or other issues preventing accurate Goldmann applanation tonometry
- prior intraocular surgery
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
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Narrow Angle Glaucoma Study Group
Subjects will be given 10ml/kg of water over 15 min prior to surgery and Intra-ocular pressure measurement (IOP) is checked every 15 min before and after surgical procedure.
|
Subjects will be given 10ml/kg of water over 15 min prior to laser peripheral iridotomy (LPI) surgery and Intra-ocular pressure (IOP) is tested every 15 min before and after surgical procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intra-ocular pressure measurement
Time Frame: every 15 minutes before and after surgery for upto an hour
|
Twenty patients with occludable angles will be enrolled in this study.
After measuring the baseline Intra-ocular pressure, weight and height, the patients will be asked to drink 10ml/kg water over 15 minutes (equal to approximately 2 ½ cups for a 150 lb.
individual) and their intra-ocular pressure (IOP) will be checked every 15 minutes up to one hour after drinking the water.
This will be repeated after performing a laser peripheral iridotomy (LPI).
The data obtained, mainly Intra-ocular pressure will be analyzed using statistical tests and compared to historical controls of the WDT without narrow angles, and laser iridotomy subjects without the WDT.
|
every 15 minutes before and after surgery for upto an hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jonathan Myers, MD, Wills Eye
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
February 1, 2010
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
August 10, 2015
First Submitted That Met QC Criteria
November 19, 2015
First Posted (Estimate)
November 24, 2015
Study Record Updates
Last Update Posted (Actual)
November 30, 2017
Last Update Submitted That Met QC Criteria
November 28, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-988E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
A manuscript has been accepted for publication in Patient Preference and Adherence.
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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