DehydrationNCT01503996
Drinking Habits of Glaucoma Patients and Age Matched Controls
An observational study of Dehydration and Glaucoma, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The purpose of this study is to examine if a chronic dehydration is a risk factor for the developement or progression of some forms of glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dehydration, Glaucoma
- What is being tested?
- alter drinking habits
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 600 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2011to Oct 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Glaucoma patients who are hospitalized for diurnal intraocular pressure measurements and glaucoma assessment. Controls who are hospitalizes because of an other ophthalmic disease and do not suffer from glaucoma.
Who may be able to join
- glaucoma patients
- controls
Who cannot join
- psychiatric disease,
- epilepsy, pregnancy,
- nutritional disorder,
- malfunction of blood clotting and wound healing,
- pacemaker,
- metallic stents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Evaluate the Drinking Habits of Glaucoma Patients and Age Matched Controls
The purpose of this study is to examine if a chronic dehydration is a risk factor for the developement or progression of some forms of glaucoma.
Read the detailed description
Glaucoma patients who are hospitalized for diurnal intraocular pressure measurements and glaucoma assessment are asked about their drinking habits. Objective evaluation of hydration status is assessed with the Body Composition Monitor (Fresenius). Retinal Vessel Analysis and Laser Doppler Flowmetry are investigated in subgroups.
The control group are also hospitalized patients who do not suffer from glaucoma.
- Conditions
- Dehydration, Glaucoma
- Being tested
- alter drinking habits
- Keywords
- dehydration, risk factor, glaucoma, Controls
- Medical subject headings
- Dehydration, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alter drinking habitsBehavioural
if dehydration is apparent, more fluid intake is recommended
| Study group | Role | What they receive |
|---|---|---|
| glaucoma | hospitalized glaucoma patients Receives: Behavioral: alter drinking habits | |
| controls | hospitalized patients without glaucoma Receives: Behavioral: alter drinking habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dehydration
The composition of a patient's body, in particular a patient's water content are determined with bioimpedance spectroscopy (Body Composition Monitor, FRESENIUS)
Measured: 4 years
Secondary outcomes (1)
microvascular changes
To investigate differences in retinal vessel diameters measured with the Retinal Vessel Analyzer (RVA, IMEDOS) in glaucoma patients and controls
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionOct 2015
- Study completionOct 2015
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 DehydrationStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe 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
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Karin Pillunat, Technische Universität Dresden
- Investigators
- Karin R Pillunat, MD, Principal investigator, University Eye Clinic Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503996
- Sponsor's protocol ID
- Drinking/Glaucoma
- Status last verified
- Nov 2015
- First submitted
- 1 Dec 2011
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Pillunat KR, Ventzke S, Spoerl E, Furashova O, Stodtmeister R, Pillunat LE. Central retinal venous pulsation pressure in different stages of primary open-angle glaucoma. Br J Ophthalmol. 2014 Oct;98(10):1374-8. doi: 10.1136/bjophthalmol-2014-305126. Epub 2014 May 12.
PubMed 24820045
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Drinking Habits of Glaucoma Patients and Age Matched Controls
- ClinicalTrials.gov ID
- NCT01503996
- Acronym / sponsor ID
- Drinking/Glaucoma
- Conditions
- Dehydration, Glaucoma
- Keywords
- dehydration, risk factor, glaucoma, Controls
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 4 Jan 2012 (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 purpose of this study is to examine if a chronic dehydration is a risk factor for the developement or progression of some forms of glaucoma.
Detailed description
Glaucoma patients who are hospitalized for diurnal intraocular pressure measurements and glaucoma assessment are asked about their drinking habits. Objective evaluation of hydration status is assessed with the Body Composition Monitor (Fresenius). Retinal Vessel Analysis and Laser Doppler Flowmetry are investigated in subgroups.
The control group are also hospitalized patients who do not suffer from glaucoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| glaucoma | – | Behavioral: alter drinking habitshospitalized glaucoma patients |
| controls | – | Behavioral: alter drinking habitshospitalized patients without glaucoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Glaucoma patients who are hospitalized for diurnal intraocular pressure measurements and glaucoma assessment. Controls who are hospitalizes because of an other ophthalmic disease and do not suffer from glaucoma.
Key inclusion criteria (2 listed)
- glaucoma patients
- controls
Key exclusion criteria (6 listed)
- psychiatric disease,
- epilepsy, pregnancy,
- nutritional disorder,
- malfunction of blood clotting and wound healing,
- pacemaker,
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 |
|---|---|---|
| alter drinking habitsif dehydration is apparent, more fluid intake is recommended | Behavioural | controls, glaucoma |
Primary outcome
Dehydration
Time frame: 4 years
The composition of a patient's body, in particular a patient's water content are determined with bioimpedance spectroscopy (Body Composition Monitor, FRESENIUS)
1 secondary outcome
microvascular changes
Time frame: 4 years
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 2015.
- Derived from this study: PubMed 24820045Pillunat KR, Ventzke S, Spoerl E, Furashova O, Stodtmeister R, Pillunat LE. Central retinal venous pulsation pressure in different stages of primary open-angle glaucoma. Br J Ophthalmol. 2014 Oct;98(10):1374-8. doi: 10.1136/bjophthalmol-2014-305126. Epub 2014 May 12.
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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.
Karin R Pillunat, MD principal investigator
University Eye Clinic Dresden
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 Dehydration and Glaucoma, run by Technische Universität Dresden at 1 site in Germany.
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 6 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 2015. 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 Germany. 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?
Dehydration (time frame: 4 years). 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 NCT01503996, 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 30 Nov 2015; AzTrials last refreshed its copy on 7 Nov 2026.