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Water Drinking Test Study and Disc Hemorrhages in Normal Tension Glaucoma

Sponsor
University of Manitoba (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05075369
Collaborator
(none)
20
Enrollment
2
Arms
6
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: water drinking test
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
patients with a diagnosis of normal tension glaucoma and noted to have a disc hemorrhagepatients with a diagnosis of normal tension glaucoma and noted to have a disc hemorrhage
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Correlation Between Water Drinking Test Study and Disc Hemorrhages in Normal Tension Glaucoma
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: baseline Intraocular pressure

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

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

Outcome Measures

Primary Outcome Measures

  1. Change in baseline intraocular pressure(IOP) with water drinking test [The water drinking test takes 60 minutes, and the participant is then finished and can leave.]

    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 .

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Manitoba

Investigators

  • Principal Investigator: Lisa Gould, MD FRCS, University of Manitoba

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Lisa Gould, Lisa Gould Associate Professor, University of Manitoba
ClinicalTrials.gov Identifier:
NCT05075369
Other Study ID Numbers:
  • B2021 060
  • Karla Zuniga
First Posted:
Oct 12, 2021
Last Update Posted:
Oct 12, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lisa Gould, Lisa Gould Associate Professor, University of Manitoba
normal tension glaucoma
disc hemorrhages
water drinking test
Additional relevant MeSH terms:
Glaucoma
Low Tension Glaucoma
Hemorrhage

Study Results

No Results Posted as of Oct 12, 2021