Drinking Habits of Glaucoma Patients and Age Matched Controls
This study is currently recruiting participants.
Verified January 2012 by Dresden University of Technology
Sponsor:
Dresden University of Technology
Information provided by (Responsible Party):
Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT01503996
First received: December 1, 2011
Last updated: January 2, 2012
Last verified: January 2012
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | December 1, 2011 | ||||||||
| Last Updated Date | January 2, 2012 | ||||||||
| Start Date ICMJE | October 2011 | ||||||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Dehydration [ Time Frame: 2 years ] [ Designated as safety issue: No ] The composition of a patient's body, in particular a patient's water content are determined with bioimpedance spectroskopy (Body Composition Monitor, FRESENIUS) |
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01503996 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
microvascular changes [ Time Frame: 2 years ] [ Designated as safety issue: No ] To investigate differences in retinal vessel diameters measured with the Retinal Vessel Analyzer (RVA, IMEDOS) in glaucoma patients and controls |
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Drinking Habits of Glaucoma Patients and Age Matched Controls | ||||||||
| Official Title ICMJE | Clinical Study to Evaluate the Drinking Habits of Glaucoma Patients and Age Matched Controls | ||||||||
| Brief 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. |
||||||||
| 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 Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| 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. |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE | Behavioral: alter drinking habits
if dehydration is apparent, more fluid intake is recommended |
||||||||
| Study Group/Cohort (s) |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 1300 | ||||||||
| Estimated Completion Date | October 2014 | ||||||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01503996 | ||||||||
| Other Study ID Numbers ICMJE | Drinking/Glaucoma | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Dresden University of Technology | ||||||||
| Study Sponsor ICMJE | Dresden University of Technology | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Dresden University of Technology | ||||||||
| Verification Date | January 2012 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||