Water Drinking Test Study and Disc Hemorrhages in Normal Tension Glaucoma

NCT ID: NCT05075369

Last Updated: 2021-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-31

Study Completion Date

2022-04-30

Brief Summary

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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

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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.

Conditions

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Normal Tension Glaucoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

patients with a diagnosis of normal tension glaucoma and noted to have a disc hemorrhage
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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baseline Intraocular pressure

The participants will have their intraocular pressure measured with Goldmann Application Tonometry immediately prior to beginning the water drinking test.

Group Type NO_INTERVENTION

No interventions assigned to this group

Change in Intraocular pressure with Water drinking test

The participants will undergo the water drinking test as previously described, i.e. after drinking 800 mls of water over a 5 minute period, the intraocular pressure will be measured immediately after completion of ingestion, followed by intraocular pressure measurements every 15 minutes for 60 minutes, using etc Goldmann apllantion tonometer.

Group Type ACTIVE_COMPARATOR

water drinking test

Intervention Type DIAGNOSTIC_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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Lisa Gould

Lisa Gould Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lisa Gould, MD FRCS

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Central Contacts

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Lisa Gould, MD, FRCS

Role: CONTACT

204-957-3252

Karla Zuniga, MD

Role: CONTACT

204-583-2762

References

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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.

Reference Type BACKGROUND
PMID: 16170120 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28164419 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10926977 (View on PubMed)

Other Identifiers

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Karla Zuniga

Identifier Type: OTHER

Identifier Source: secondary_id

B2021 060

Identifier Type: -

Identifier Source: org_study_id