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Water Drinking Test Study and Disc Hemorrhages in Normal Tension Glaucoma

Primary Purpose

Normal Tension Glaucoma

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
water drinking test
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Normal Tension Glaucoma focused on measuring normal tension glaucoma, disc hemorrhages, water drinking test

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    baseline Intraocular pressure

    Change in Intraocular pressure with Water drinking test

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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 .

    Secondary Outcome Measures

    Full Information

    First Posted
    September 19, 2021
    Last Updated
    September 29, 2021
    Sponsor
    University of Manitoba
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05075369
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2021 (Anticipated)
    Primary Completion Date
    April 2022 (Anticipated)
    Study Completion Date
    April 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Manitoba

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Normal Tension Glaucoma
    Keywords
    normal tension glaucoma, disc hemorrhages, water drinking test

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    patients with a diagnosis of normal tension glaucoma and noted to have a disc hemorrhage
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    baseline Intraocular pressure
    Arm Type
    No Intervention
    Arm Description
    The participants will have their intraocular pressure measured with Goldmann Application Tonometry immediately prior to beginning the water drinking test.
    Arm Title
    Change in Intraocular pressure with Water drinking test
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    water drinking test
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Change in baseline intraocular pressure(IOP) with water drinking test
    Description
    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 .
    Time Frame
    The water drinking test takes 60 minutes, and the participant is then finished and can leave.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lisa Gould, MD, FRCS
    Phone
    204-957-3252
    Email
    lisa.gould@umanitoba.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Karla Zuniga, MD
    Phone
    204-583-2762
    Email
    kzunigak@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lisa Gould, MD FRCS
    Organizational Affiliation
    University of Manitoba
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Individual participant data that underlie the results reported in the paper or poster , after deidentification (text, tables, figures, and appendices) will be available
    IPD Sharing Time Frame
    Immediately upon publication and for 36 months afterwards
    IPD Sharing Access Criteria
    Researchers who provide a methodologically sound proposal.
    Citations:
    PubMed Identifier
    16170120
    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.
    Results Reference
    background
    PubMed Identifier
    28164419
    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.
    Results Reference
    background
    PubMed Identifier
    10926977
    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.
    Results Reference
    background

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    Water Drinking Test Study and Disc Hemorrhages in Normal Tension Glaucoma

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