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Water Drinking Test in Patients With Occludable Angle

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intra-ocular pressure measurement (IOP)
Sponsored by
Wills Eye
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Glaucoma

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wills Eye Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Narrow Angle Glaucoma Study Group

Arm Description

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.

Outcomes

Primary Outcome Measures

Intra-ocular pressure measurement
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.

Secondary Outcome Measures

Full Information

First Posted
August 10, 2015
Last Updated
November 28, 2017
Sponsor
Wills Eye
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1. Study Identification

Unique Protocol Identification Number
NCT02613533
Brief Title
Water Drinking Test in Patients With Occludable Angle
Official Title
What is the Effect of the "Water Drinking Test" on Patients With Narrow Angles on the Day of Their Scheduled Laser Iridotomy?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Narrow Angle Glaucoma Study Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Intra-ocular pressure measurement (IOP)
Intervention Description
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
Primary Outcome Measure Information:
Title
Intra-ocular pressure measurement
Description
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.
Time Frame
every 15 minutes before and after surgery for upto an hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Myers, MD
Organizational Affiliation
Wills Eye
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wills Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
A manuscript has been accepted for publication in Patient Preference and Adherence.

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Water Drinking Test in Patients With Occludable Angle

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