GlaucomaNCT02001155
Comparing the Effect of the Water Drinking Test on Intraocular Pressure
An observational study of Glaucoma, run by Wills Eye at 1 site in United States.
Trial summary
A test that was common in the 1960's and was used to detect primary open angle glaucoma was the water drinking test (patients drank 1 quart of water to stress the fluid drainage mechanism of the eyes. Intraocular pressure was then measured over the next hour). Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Water Drinking Test
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jul 2014
- Phase
- Observational
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All participants will have open angle glaucoma and have undergone either tube shunt surgery or trabeculectomy. All participants will be matched for range of recent intraocular pressure (average over the prior three visits of <12 mm Hg, 12 to <18 mm Hg, or >18 mm Hg), as well as number of medications (none, 1-2, 3 or more).
Who may be able to join
- prior trabeculectomy or tube shunt for the treatment of glaucoma
- age 21-90 years
Who cannot join
- inability to give informed consent
- current ocular infection
- more than 1 prior trabeculectomy, or more than 1 prior tube shunt
- previous refractive surgery
- pregnant women
- heart failure
- renal failure or uncontrolled urine retention
- corneal abnormalities preventing reliable IOP measurement
Trial locations and contacts
1 site in 1 country.
United States1 site
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Comparing the Effect of the Water Drinking Test on Intraocular Pressure in Patients With Prior Trabeculectomy or Tube Shunt Surgeries
A test that was common in the 1960's and was used to detect primary open angle glaucoma was the water drinking test (patients drank 1 quart of water to stress the fluid drainage mechanism of the eyes. Intraocular pressure was then measured over the next hour). Recently this test has been demonstrated as a predictor of peak eye pressure during the day. The purpose of this study is to compare the results of the water drinking test between eyes that have undergone trabeculectomy and eyes that have undergone tube shunt surgery.
- Conditions
- Glaucoma
- Being tested
- Water Drinking Test
- Keywords
- Water drinking test, trabeculectomy, tube shunt
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water Drinking TestProcedure or surgery
The Water Drinking test has been identified as a reliable and safe tool to predict maximum intraocular pressure values during a diurnal tension curve and to assess the efficacy of surgical interventions. Participants are asked to drink 10 ml/kg water (or approximately 0.33 ounces of water for every 2.2 pounds of weight or about 2.5 cups for a 150 lb. individual) over 15 minutes. Intraocular pressure is assessed every 15 minutes for one hour.
| Study group | Role | What they receive |
|---|---|---|
| Trabeculectomy | Individuals in this group will have undergone a trabeculectomy for the treatment of glaucoma. Receives: Procedure: Water Drinking Test | |
| Tube Shunt | Individuals in this group will have undergone a tube shunt for the treatment of glaucoma. Receives: Procedure: Water Drinking Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure (IOP)
IOP is assessed every 15 minutes for one hour after the water drinking test is complete.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startJul 2013
- Primary completionFeb 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathon Myers, Wills Eye
- Investigators
- Jonathan Myers, MD, Principal investigator, Wills Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001155
- Sponsor's protocol ID
- WEH - 10-989E
- Status last verified
- Nov 2016
- First submitted
- 26 Nov 2013
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: A manuscript is currently under development.
Publications
Waisbourd M, Savant SV, Sun Y, Martinez P, Myers JS. Water-drinking test in primary angle-closure suspect before and after laser peripheral iridotomy. Clin Exp Ophthalmol. 2016 Mar;44(2):89-94. doi: 10.1111/ceo.12639. Epub 2015 Nov 10.
PubMed 26332426
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effect of the Water Drinking Test on Intraocular Pressure in Patients With Prior Trabeculectomy or Tube Shunt Surgeries
- ClinicalTrials.gov ID
- NCT02001155
- Acronym / sponsor ID
- WEH - 10-989E
- Conditions
- Glaucoma
- Keywords
- Water drinking test, trabeculectomy, tube shunt
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 4 Dec 2013 (estimated)
- 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.
A test that was common in the 1960's and was used to detect primary open angle glaucoma was the water drinking test (patients drank 1 quart of water to stress the fluid drainage mechanism of the eyes. Intraocular pressure was then measured over the next hour). Recently this test has been demonstrated as a predictor of peak eye pressure during the day. The purpose of this study is to compare the results of the water drinking test between eyes that have undergone trabeculectomy and eyes that have undergone tube shunt surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trabeculectomy | – | Procedure: Water Drinking TestIndividuals in this group will have undergone a trabeculectomy for the treatment of glaucoma. |
| Tube Shunt | – | Procedure: Water Drinking TestIndividuals in this group will have undergone a tube shunt for the treatment of glaucoma. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants will have open angle glaucoma and have undergone either tube shunt surgery or trabeculectomy. All participants will be matched for range of recent intraocular pressure (average over the prior three visits of <12 mm Hg, 12 to <18 mm Hg, or >18 mm Hg), as well as number of medications (none, 1-2, 3 or more).
Key inclusion criteria (2 listed)
- prior trabeculectomy or tube shunt for the treatment of glaucoma
- age 21-90 years
Key exclusion criteria (8 listed)
- inability to give informed consent
- current ocular infection
- more than 1 prior trabeculectomy, or more than 1 prior tube shunt
- previous refractive surgery
- pregnant women
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 TestThe Water Drinking test has been identified as a reliable and safe tool to predict maximum intraocular pressure values during a diurnal tension curve and to assess the efficacy of surgical interventions. Participants are asked to drink 10 ml/kg water (or approximately 0.33 ounces of water for every 2.2 pounds of weight or about 2.5 cups for a 150 lb. individual) over 15 minutes. Intraocular pressure is assessed every 15 minutes for one hour. | Procedure or surgery | Trabeculectomy, Tube Shunt |
Primary outcome
Intraocular Pressure (IOP)
Time frame: 1 hour
IOP is assessed every 15 minutes for one hour after the water drinking test is complete.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2016.
- Background: PubMed 26332426Waisbourd M, Savant SV, Sun Y, Martinez P, Myers JS. Water-drinking test in primary angle-closure suspect before and after laser peripheral iridotomy. Clin Exp Ophthalmol. 2016 Mar;44(2):89-94. doi: 10.1111/ceo.12639. Epub 2015 Nov 10.
- Individual participant dataSharing planned: Yes. A manuscript is currently under development.
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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.
Jonathan Myers, MD principal investigator
Wills Eye Hospital
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 Wills Eye at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 10 Nov 2016. 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intraocular Pressure (IOP) (time frame: 1 hour). 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 NCT02001155, 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 10 Nov 2016.