Water Drinking Test Study and Disc Hemorrhages in Normal Tension Glaucoma

Normal Tension Glaucoma Clinical Trial

Official title:

Correlation Between Water Drinking Test Study and Disc Hemorrhages in Normal Tension Glaucoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05075369
• Other study ID #: B2021 060
• Secondary ID: Karla Zuniga
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2021
• Est. completion date: April 2022

Study information

• Verified date: September 2021
• Source: University of Manitoba
• Contact: Lisa Gould, MD, FRCS
• Phone: 204-957-3252
• Email: lisa.gould[@]umanitoba.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Disc hemorrhages are a known risk factor for progression of glaucoma. A positive water drinking test is also associated with progression of primary open glaucoma. The purpose of this study is to determine if patients with normal tension glaucoma and disc hemorrhages have a positive water drinking test. Patients with normal tension glaucoma and a disc hemorrhage will be recruited to undergo a water drinking test prior to any change in their treatment.

Description:

Patient with normal tension glaucoma under the care of a fellowship trained glaucoma specialist and noted to have a disc hemorrhage in one or both eyes when examined in the office will be recruited to undergo a water drinking test (WDT). After an informed consent is obtained, arrangements will be made to undergo the WDT either at the ophthalmologist's office or the local hospital clinic(Misericordia). The test will be administered in the following way: Upon arrival the patients baseline intraocular pressure (IOP) will be measured, then shortly afterwards the patient will drink 800 ml of water in a period of 5 minutes. Immediately after the water ingestion has finished a second IOP will be measured, followed by IOP measurements every 15 minutes for 60 minutes with a Goldman applanation tonometer by the same examiner. All of these measurements will be collected in a data sheet for the WTD. A total of 60 minutes would be the duration of the activity.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of normal tension glaucoma by a fellowship trained glaucoma specialist,
• Clinical diagnosis of a disc hemorrhage diagnosed by a fellowship trained glaucoma specialist,
• Must be able to swallow water
• Must be able to be positioned to allow accurate measurement of the Intraocular pressure with a slit lamp mounted Goldmann applanation tonometer
• Must have a smooth corneal surface to allow for accurate Goldmann application tonometry measurement
• Outpatient
• A sufficient level of education to understand study procedures and be able to communicate with site personnel

Exclusion Criteria:

• History of refractive surgery,
• Active ocular infection,
• Pregnancy,
• Cardiac or renal diseases, history of urinary retention,
• Corneal abnormalities preventing reliable IOP measurements,
• Previous trabeculectomy or glaucoma shunt surgery,
• Previous laser iridotomy,
• Cognitive impairment or language barrier preventing ability to provide an informed consent.

Related Conditions & MeSH terms

• Glaucoma
• Hemorrhage
• Low Tension Glaucoma
• Normal Tension Glaucoma

Intervention

Diagnostic Test:
• water drinking test
Water drinking test-glaucoma diagnostic test - marker for outflow facility reserve to detect IOP instability when the body ingests 800 ml of water within a 5 minute period of time

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

References & Publications (3)

Ishida K, Yamamoto T, Sugiyama K, Kitazawa Y. Disk hemorrhage is a significantly negative prognostic factor in normal-tension glaucoma. Am J Ophthalmol. 2000 Jun;129(6):707-14. — View Citation

Susanna R Jr, Clement C, Goldberg I, Hatanaka M. Applications of the water drinking test in glaucoma management. Clin Exp Ophthalmol. 2017 Aug;45(6):625-631. doi: 10.1111/ceo.12925. Epub 2017 Mar 9. Review. — View Citation

Susanna R Jr, Vessani RM, Sakata L, Zacarias LC, Hatanaka M. The relation between intraocular pressure peak in the water drinking test and visual field progression in glaucoma. Br J Ophthalmol. 2005 Oct;89(10):1298-301. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in baseline intraocular pressure(IOP) with water drinking test	The change in intraocular pressure in patients with normal tension glaucoma and a disc hemorrhage after undergoing the water drinking test will be measured with Goldmann applanation tonometry. A change from baseline IOP of 5 mm Hg is considered abnormal .	The water drinking test takes 60 minutes, and the participant is then finished and can leave.