Water Drinking Test Study and Disc Hemorrhages in Normal Tension Glaucoma

NCT05075369 | Unknown

• 2 other identifiers: B2021 060Karla Zuniga
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Normal Tension Glaucoma

Keywords

normal tension glaucoma; disc hemorrhages; water drinking test

Outcome Measures

Primary Outcomes (1)

• 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 .

  The water drinking test takes 60 minutes, and the participant is then finished and can leave.

Study Arms (2)

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.

Diagnostic Test: water drinking test

Interventions

water drinking test 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

Change in Intraocular pressure with Water drinking test

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead

Related Publications (3)

• 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.

  PMID: 16170120 BACKGROUND

• 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.

  PMID: 28164419 BACKGROUND

• 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.

  PMID: 10926977 BACKGROUND

MeSH Terms

Conditions

Low Tension Glaucoma

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Optic Nerve Diseases

Study Officials

• Lisa Gould, MD FRCS

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Gould, MD, FRCS

CONTACT

204-957-3252; lisa.gould@umanitoba.ca

Karla Zuniga, MD

CONTACT

204-583-2762; kzunigak@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lisa Gould Associate Professor

Model Details: patients with a diagnosis of normal tension glaucoma and noted to have a disc hemorrhage

Study Record Dates

• First Submitted: September 19, 2021
• First Posted: October 12, 2021
• Study Start: October 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: October 12, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Immediately upon publication and for 36 months afterwards
• Access Criteria: Researchers who provide a methodologically sound proposal.