GlaucomaNCT02613533
Water Drinking Test in Patients With Occludable Angle
A study testing Intra-ocular pressure measurement (IOP) in people with Glaucoma, run by Wills Eye at 1 site in United States.
Trial summary
The water drinking test (WDT), is a predictive test that has been used to detect primary open angle glaucoma and recently has been demonstrated as a predictor of the diurnal tension curve. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Intra-ocular pressure measurement (IOP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Jan 2015
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- narrow angle judged to be at risk of attack by the treating physician, with one or more quadrants not open to the sclera spur on gonioscopy
- age between 21 and 90 years
- ability to give informed consent.
Who cannot join
- baseline IOP higher than 21 mm Hg with or without medication
- other causes of glaucoma, such as pseudoexfoliative and pigmentary glaucomas
- previous treatment with argon laser or selective laser trabeculoplasty
- previous refractive sugary; (5) pregnant women; (6) congestive heart failure
- renal failure or urinary retention issues; (8) corneal abnormalities preventing reliable IOP measurement
- non-glaucomatous optic neuropathy
- prior refractive surgery or other issues preventing accurate Goldmann applanation tonometry
- prior intraocular surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Wills Eye Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: What is the Effect of the "Water Drinking Test" on Patients With Narrow Angles on the Day of Their Scheduled Laser Iridotomy?
The water drinking test (WDT), is a predictive test that has been used to detect primary open angle glaucoma and recently has been demonstrated as a predictor of the diurnal tension curve. Clinically accurate provocative tests for asymptomatic eyes with shallow anterior chambers and narrow angles are highly desirable to detect patients prone to angle closure glaucoma. The aim of this pilot study is to evaluate the possible role of water drinking test in patients with narrow angles who are scheduled for prophylactic laser iridotomy.
Read the detailed description
This prospective case series will investigate the effects of the WDT on subjects with narrow anterior chamber angles on the day of their scheduled laser iridotomy. The angle configuration and IOP will be monitored following the WDT. Twenty patients with occludable angles will be enrolled in this study. After measuring the baseline IOP, weight and height, the patients will be asked to drink 10ml/kg water over 15 minutes (equal to approximately 0.33 ounces of water for every 2.2 pounds of weight or 2 ½ cups for a 150 lb. individual) and their IOP will be checked every 15 minutes up to one hour after drinking the water. This will be repeated after performing a laser iridotomy. The data obtained, mainly IOP and gonioscopic findings, will be analyzed using statistical tests and compared to historical controls of the WDT without narrow angles, and laser iridotomy subjects without the WDT.
- Conditions
- Glaucoma
- Being tested
- Intra-ocular pressure measurement (IOP)
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-ocular pressure measurement (IOP)Other
Subjects will be given 10ml/kg of water over 15 min prior to laser peripheral iridotomy (LPI) surgery and Intra-ocular pressure (IOP) is tested every 15 min before and after surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Narrow Angle Glaucoma Study Group | Experimental | Subjects will be given 10ml/kg of water over 15 min prior to surgery and Intra-ocular pressure measurement (IOP) is checked every 15 min before and after surgical procedure. Receives: Other: Intra-ocular pressure measurement (IOP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-ocular pressure measurement
Twenty patients with occludable angles will be enrolled in this study. After measuring the baseline Intra-ocular pressure, weight and height, the patients will be asked to drink 10ml/kg water over 15 minutes (equal to approximately 2 ½ cups for a 150 lb. individual) and their intra-ocular pressure (IOP) will be checked every 15 minutes up to one hour after drinking the water. This will be repeated after performing a laser peripheral iridotomy (LPI). The data obtained, mainly Intra-ocular pressure will be analyzed using statistical tests and compared to historical controls of the WDT without narrow angles, and laser iridotomy subjects without the WDT.
Measured: every 15 minutes before and after surgery for upto an hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startFeb 2010
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613533
- Sponsor's protocol ID
- 10-988E
- Status last verified
- Nov 2017
- First submitted
- 10 Aug 2015
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: A manuscript has been accepted for publication in Patient Preference and Adherence.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Effect of the "Water Drinking Test" on Patients With Narrow Angles on the Day of Their Scheduled Laser Iridotomy?
- ClinicalTrials.gov ID
- NCT02613533
- Acronym / sponsor ID
- 10-988E
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 24 Nov 2015 (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.
The water drinking test (WDT), is a predictive test that has been used to detect primary open angle glaucoma and recently has been demonstrated as a predictor of the diurnal tension curve. Clinically accurate provocative tests for asymptomatic eyes with shallow anterior chambers and narrow angles are highly desirable to detect patients prone to angle closure glaucoma. The aim of this pilot study is to evaluate the possible role of water drinking test in patients with narrow angles who are scheduled for prophylactic laser iridotomy.
Detailed description
This prospective case series will investigate the effects of the WDT on subjects with narrow anterior chamber angles on the day of their scheduled laser iridotomy. The angle configuration and IOP will be monitored following the WDT. Twenty patients with occludable angles will be enrolled in this study. After measuring the baseline IOP, weight and height, the patients will be asked to drink 10ml/kg water over 15 minutes (equal to approximately 0.33 ounces of water for every 2.2 pounds of weight or 2 ½ cups for a 150 lb. individual) and their IOP will be checked every 15 minutes up to one hour after drinking the water. This will be repeated after performing a laser iridotomy. The data obtained, mainly IOP and gonioscopic findings, will be analyzed using statistical tests and compared to historical controls of the WDT without narrow angles, and laser iridotomy subjects without the WDT.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Narrow Angle Glaucoma Study Group | Experimental | Other: Intra-ocular pressure measurement (IOP)Subjects will be given 10ml/kg of water over 15 min prior to surgery and Intra-ocular pressure measurement (IOP) is checked every 15 min before and after surgical procedure. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- narrow angle judged to be at risk of attack by the treating physician, with one or more quadrants not open to the sclera spur on gonioscopy
- age between 21 and 90 years
- ability to give informed consent.
Key exclusion criteria (8 listed)
- baseline IOP higher than 21 mm Hg with or without medication
- other causes of glaucoma, such as pseudoexfoliative and pigmentary glaucomas
- previous treatment with argon laser or selective laser trabeculoplasty
- previous refractive sugary; (5) pregnant women; (6) congestive heart failure
- renal failure or urinary retention issues; (8) corneal abnormalities preventing reliable IOP measurement
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 |
|---|---|---|
| Intra-ocular pressure measurement (IOP)Subjects will be given 10ml/kg of water over 15 min prior to laser peripheral iridotomy (LPI) surgery and Intra-ocular pressure (IOP) is tested every 15 min before and after surgical procedure | Other | Narrow Angle Glaucoma Study Group |
Primary outcome
Intra-ocular pressure measurement
Time frame: every 15 minutes before and after surgery for upto an hour
Twenty patients with occludable angles will be enrolled in this study. After measuring the baseline Intra-ocular pressure, weight and height, the patients will be asked to drink 10ml/kg water over 15 minutes (equal to approximately 2 ½ cups for a 150 lb. individual) and their intra-ocular pressure (IOP) will be checked every 15 minutes up to one hour after drinking the water. This will be repeated after performing a laser peripheral iridotomy (LPI). The data obtained, mainly Intra-ocular pressure will be analyzed using statistical tests and compared to historical controls of the WDT without narrow angles, and laser iridotomy subjects without the WDT.
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 30 Nov 2017.
- Individual participant dataSharing planned: No. A manuscript has been accepted for publication in Patient Preference and Adherence.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-ocular pressure measurement (IOP) in people with 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 3 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 30 Nov 2017. 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?
Intra-ocular pressure measurement (time frame: every 15 minutes before and after surgery for upto an hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Nov 2017.