Clinical trial NCT05075369: Water Drinking Test Study and Disc Hemorrhages in Normal Tension Glaucoma
Official title: Correlation Between Water Drinking Test Study and Disc Hemorrhages in Normal Tension Glaucoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Normal Tension Glaucoma
Keywords: normal tension glaucoma
disc hemorrhages
water drinking test
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: patients with a diagnosis of normal tension glaucoma and noted to have a disc hemorrhage
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in baseline intraocular pressure(IOP) with water drinking test
timeFrame: The water drinking test takes 60 minutes, and the participant is then finished and can leave.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Manitoba
name: Lisa Gould, MD FRCS
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1136/bjo.2005.070649.
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.
citation: 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. doi: 10.1016/s0002-9394(00)00441-4.