NCT02613533

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 24, 2015

Completed
Last Updated

November 30, 2017

Status Verified

November 1, 2017

Enrollment Period

4.9 years

First QC Date

August 10, 2015

Last Update Submit

November 28, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    every 15 minutes before and after surgery for upto an hour

Study Arms (1)

Narrow Angle Glaucoma Study Group

EXPERIMENTAL

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)

Interventions

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

Narrow Angle Glaucoma Study Group

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Jonathan Myers, MD

    Wills Eye

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

August 10, 2015

First Posted

November 24, 2015

Study Start

February 1, 2010

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

November 30, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

A manuscript has been accepted for publication in Patient Preference and Adherence.

Locations