Normal Tension GlaucomaNCT05075369
Water Drinking Test Study and Disc Hemorrhages in Normal Tension Glaucoma
A study testing water drinking test in people with Normal Tension Glaucoma, run by University of Manitoba.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Normal Tension Glaucoma
- What is being tested?
- water drinking test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Correlation Between Water Drinking Test Study and Disc Hemorrhages in Normal Tension Glaucoma
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.
Read the 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.
- Conditions
- Normal Tension Glaucoma
- Being tested
- water drinking test
- Keywords
- normal tension glaucoma, disc hemorrhages, water drinking test
- Medical subject headings
- Low Tension Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water drinking testDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| baseline Intraocular pressure | No intervention | The participants will have their intraocular pressure measured with Goldmann Application Tonometry immediately prior to beginning the water drinking test. |
| Change in Intraocular pressure with Water drinking test | Active comparator | 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. Receives: Diagnostic Test: water drinking test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: The water drinking test takes 60 minutes, and the participant is then finished and can leave.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study startOct 2021 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Normal Tension GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- patients with a diagnosis of normal tension glaucoma and noted to have a disc hemorrhage
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Gould, University of Manitoba
- Investigators
- Lisa Gould, MD FRCS, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075369
- Sponsor's protocol ID
- B2021 060
- Other IDs
- Karla Zuniga
- Status last verified
- Sep 2021
- First submitted
- 19 Sep 2021
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the paper or poster , after deidentification (text, tables, figures, and appendices) will be available
Publications
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.
PubMed 16170120Susanna 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.
PubMed 28164419Ishida 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.
PubMed 10926977
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Water Drinking Test Study and Disc Hemorrhages in Normal Tension Glaucoma
- ClinicalTrials.gov ID
- NCT05075369
- Acronym / sponsor ID
- B2021 060
- Conditions
- Normal Tension Glaucoma
- Keywords
- normal tension glaucoma, disc hemorrhages, water drinking test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- patients with a diagnosis of normal tension glaucoma and noted to have a disc hemorrhage
| Arm | Type | Receives |
|---|---|---|
| baseline Intraocular pressure | No intervention | –The participants will have their intraocular pressure measured with Goldmann Application Tonometry immediately prior to beginning the water drinking test. |
| Change in Intraocular pressure with Water drinking test | Active comparator | Diagnostic Test: water drinking testThe 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- History of refractive surgery,
- Active ocular infection,
- Pregnancy,
- Cardiac or renal diseases, history of urinary retention,
- Corneal abnormalities preventing reliable IOP measurements,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| water drinking testWater 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 | Diagnostic test | Change in Intraocular pressure with Water drinking test |
Primary outcome
Change in baseline intraocular pressure(IOP) with water drinking test
Time frame: 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 .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Background: PubMed 16170120Susanna 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.
- Background: PubMed 28164419Susanna 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.
- Background: PubMed 10926977Ishida 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the paper or poster , after deidentification (text, tables, figures, and appendices) will be available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Gould, MD FRCS principal investigator
University of Manitoba
Questions about this trial
What is this clinical trial studying?
A study testing water drinking test in people with Normal Tension Glaucoma, run by University of Manitoba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa Gould, MD, FRCS (204-957-3252, lisa.gould@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline intraocular pressure(IOP) with water drinking test (time frame: The water drinking test takes 60 minutes, and the participant is then finished and can leave.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05075369, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.