Comparing the Effect of the Water Drinking Test on Intraocular Pressure

NCT02001155 | Completed

• 1 other identifier: WEH - 10-989E
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glaucoma

Keywords

Water drinking test; trabeculectomy; tube shunt

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure (IOP)

  IOP is assessed every 15 minutes for one hour after the water drinking test is complete.

  1 hour

Study Arms (2)

Trabeculectomy

Individuals in this group will have undergone a trabeculectomy for the treatment of glaucoma.

Procedure: Water Drinking Test

Tube Shunt

Individuals in this group will have undergone a tube shunt for the treatment of glaucoma.

Procedure: Water Drinking Test

Interventions

Water Drinking Test PROCEDURE

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.

Trabeculectomy; Tube Shunt

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• prior trabeculectomy or tube shunt for the treatment of glaucoma
• age 21-90 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Wills Eye: lead

Study Sites (1)

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• Waisbourd M, Savant SV, Sun Y, Martinez P, Myers JS. Water-drinking test in primary angle-closure suspect before and after laser peripheral iridotomy. Clin Exp Ophthalmol. 2016 Mar;44(2):89-94. doi: 10.1111/ceo.12639. Epub 2015 Nov 10.

  PMID: 26332426 BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Jonathan Myers, MD

  Wills Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Ophthalmology; Director of Clinical Fellowship

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 4, 2013
• Study Start: July 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: July 1, 2014
• Last Updated: November 10, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)