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Completed

NCT Number: NCT05283031

The Water Drinking Test in Glaucoma Study

To investigate the correlation and agreement between the intraocular pressure peaks detected during the water drinking test and modified diurnal tension curve in glaucomatous eyes and to analyse whether this is associated with prognostic outcome. The study will also measure autonomic nervous system activation during the test to investigate one possible mechanism behind it.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Imperial College Ophthalmic Research Group

London, NW1 5QH, United Kingdom

About this study

Glaucoma is a progressive optic neuropathy characterized by progressive loss of retinal ganglion cells, leading to thinning of the retinal nerve fiber layer and visual field losses. It is the leading cause of irreversible blindness in the world [2] and affects more than 70 million people worldwide. Intraocular pressure (IOP) is the main risk factor for the development and progression of glaucoma. The gold standard for intraocular pressure (IOP) measurement is applanation tonometry. Routine office measurements may not detect IOP peaks in roughly 30% of patients due to variation throughout the day and this detection failure may be responsible for visual field progression in apparently well-controlled patients. Therefore this study is to investigate the correlation and agreement between the intraocular pressure peaks detected during the water drinking test and modified diurnal tension curve in glaucomatous eyes and to analyze whether this is associated with prognostic outcome. The study will also measure autonomic nervous system activation during the test to investigate one possible mechanism behind it. The primary measure is peak Intraocular pressure measurements from two different measures. Secondary measures include OCT angiography, postural blood pressure, heart rate, pupil diameter. Current and future rates of progression using visual field and optical coherence tomography (OCT) measures. This is a prospective method comparison study, of 40 primary open angle and normal tension glaucoma patients who will attend for a single visit. Inclusion criteria include those

  • Able to give informed consent to participate in the study
  • Aged between 18 and 80 years of age
  • Clear optical media
  • Spherical equivalent +-10 Dioptres
  • Normal tension glaucoma proven by visual field testing or OCT imaging combined with clinical assessment.
  • Primary open angle glaucoma proven by visual field testing or OCT imaging combined with clinical assessment

Following completion of the study, participants will be followed up in their usual clinic as part of their regular care. The participants' follow-up data which is routinely generated as part of the glaucoma care pathway will be accessed for 18 months following completion of participation with a view of correlating initial results with possible disease progression and other related outcomes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to give informed consent to participate in the study
  • Aged between 18 and 80 years of age
  • Clear optical media
  • Spherical equivalent +-10 Dioptres
  • Normal tension glaucoma proven by visual field testing or OCT imaging combined with clinical assessment.
  • Primary open angle glaucoma proven by visual field testing or OCT imaging combined with clinical assessment.

Exclusion criteria

  • Are using ocular hypotensive therapy, or have done so in the last 30 days
  • Have any other known ocular disease (except glaucoma)
  • Have serious cardiac or kidney disease (WDT contra-indication)
  • Have swallowing difficulties associated with either a neurological or gastrointestinal condition.
  • Patients with any contra-indication of drinking large amounts of water in a small period of time e.g. swallowing impairment, oesophageal stricture, gastric banding.
  • Have secondary or narrow/closed angle glaucoma
  • Patients submitted to any surgical procedure or laser intervention during the evaluation period

Treatment and study plan

Modified Diurnal Tension Curve

Diagnostic Test

The modified diurnal tension curve (mDTC), an alternative that involves IOP measurements every 2 or 3 hours during office hours, is more feasible and may provide better information regarding the IOP profile than single IOP measurements.

Primary outcomes

  1. Maximum Intraocular Pressure Difference (Between mDCT and WDT)

    Time frame: Single measurement (mDCT 5 measurements taken one every 2 hours and WDT a measurement taken every 15 minutes up to 45 minutes)

    Maximum intraocular pressure difference between two methods applied to each subject (modified diurnal tension curve mDTC and water drinking test WDT). The difference between maximum intraocular pressure of five eye pressure measurements taken at 8:00, 10:00, 12:00, 14:00 and 16:00 minus the maximum intraocular pressure measured at 15 minute intervals over 45 minutes during the water drinking test.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Acronym: WIGS

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 16, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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