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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02001155
Other study ID # WEH - 10-989E
Secondary ID
Status Completed
Phase N/A
First received November 26, 2013
Last updated November 8, 2016
Start date July 2013
Est. completion date July 2014

Study information

Verified date November 2016
Source Wills Eye
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group 21 Years to 90 Years
Eligibility Inclusion Criteria:

- prior trabeculectomy or tube shunt for the treatment of glaucoma

- age 21-90 years

Exclusion Criteria:

- 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
Water Drinking Test
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.

Locations

Country Name City State
United States Wills Eye Hospital Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Wills Eye

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Intraocular Pressure (IOP) IOP is assessed every 15 minutes for one hour after the water drinking test is complete. 1 hour No
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