Water Drinking Test in Patients With Occludable Angle

Sponsor

Wills Eye (Other)

Overall Status

Completed

CT.gov ID

NCT02613533

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Other: Intra-ocular pressure measurement (IOP)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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 Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Jan 1, 2015

Arms and Interventions

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.	Other: Intra-ocular pressure measurement (IOP) 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

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.

Other: Intra-ocular pressure measurement (IOP)

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

Outcome Measures

Primary Outcome Measures

Intra-ocular pressure measurement [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wills Eye Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

Wills Eye

Investigators

Principal Investigator: Jonathan Myers, MD, Wills Eye

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jonathon Myers, Principle Investigator, Wills Eye

ClinicalTrials.gov Identifier:

NCT02613533

Other Study ID Numbers:

10-988E

First Posted:

Nov 24, 2015

Last Update Posted:

Nov 30, 2017

Last Verified:

Nov 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Glaucoma

Study Results

No Results Posted as of Nov 30, 2017