GlaucomaWIGSNCT05283031
The Water Drinking Test in Glaucoma Study
An observational study of Glaucoma, run by Imperial College London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Modified Diurnal Tension Curve
- How many people
- 46 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Mar 2021to 9 Jun 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary open-angle and normal tension glaucoma patients
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Ophthalmic Research Group
London, NW1 5QH
About this 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.
Read the detailed description
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.
- Conditions
- Glaucoma
- Being tested
- Modified Diurnal Tension Curve
- Keywords
- Intraocular Pressure, Stress Test, Correlation, Water Drinking Test, OCT, Normal Tension Glaucoma
- Medical subject headings
- Glaucoma, Low Tension Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Diurnal Tension CurveDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Intraocular Pressure Difference (Between mDCT and WDT)
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.
Measured: Single measurement (mDCT 5 measurements taken one every 2 hours and WDT a measurement taken every 15 minutes up to 45 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start17 Mar 2021
- Primary completion9 Jun 2021
- Study completion9 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesca Cordeiro, Study chair, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283031
- Sponsor's protocol ID
- 19IC5525
- Acronym
- WIGS
- Status last verified
- Apr 2024
- First submitted
- 7 Mar 2022
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yap TE, Gao Y, Ahmad H, Susanna F, Susanna R, Normando EM, Bloom PA, Cordeiro MF. Comparison of intraocular pressure profiles during the water drinking test and the modified diurnal tension curve. Eye (Lond). 2024 Jun;38(8):1567-1574. doi: 10.1038/s41433-024-02954-0. Epub 2024 Mar 7.
PubMed 38454171
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Water Drinking Test in Glaucoma Study
- ClinicalTrials.gov ID
- NCT05283031
- Acronym / sponsor ID
- WIGS / 19IC5525
- Conditions
- Glaucoma
- Keywords
- Intraocular Pressure, Stress Test, Correlation, Water Drinking Test, OCT, Normal Tension Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 9 Jun 2021 (actual)
- Study completion
- 9 Jun 2021 (actual)
- First posted
- 16 Mar 2022 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary open-angle and normal tension glaucoma patients
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Modified Diurnal Tension CurveThe 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. | Diagnostic test | – |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38454171Yap TE, Gao Y, Ahmad H, Susanna F, Susanna R, Normando EM, Bloom PA, Cordeiro MF. Comparison of intraocular pressure profiles during the water drinking test and the modified diurnal tension curve. Eye (Lond). 2024 Jun;38(8):1567-1574. doi: 10.1038/s41433-024-02954-0. Epub 2024 Mar 7.
- Individual participant dataSharing planned: No
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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.
Francesca Cordeiro study chair
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Imperial College London at 1 site in United Kingdom.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). 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 NCT05283031, which also lists 1 linked publication.
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 19 Sep 2024.