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Drinking Habits of Glaucoma Patients and Age Matched Controls

This study is currently recruiting participants.
Verified January 2012 by Dresden University of Technology
Sponsor:
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
History of Changes
  Purpose

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.


Condition Intervention
Dehydration
Glaucoma
 Behavioral: alter drinking habits

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Study to Evaluate the Drinking Habits of Glaucoma Patients and Age Matched Controls

Resource links provided by NLM:

MedlinePlus related topics: Dehydration Glaucoma
U.S. FDA Resources

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 1300
Study Start Date: October 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
glaucoma
hospitalized glaucoma patients
 Behavioral: alter drinking habits
if dehydration is apparent, more fluid intake is recommended
controls
hospitalized patients without glaucoma
 Behavioral: alter drinking habits
if dehydration is apparent, more fluid intake is recommended

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

  • glaucoma patients
  • controls

Exclusion Criteria:

  • psychiatric disease,
  • epilepsy, pregnancy,
  • nutritional disorder,
  • malfunction of blood clotting and wound healing,
  • pacemaker,
  • metallic stents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01503996

Contacts
Contact: Karin R Pillunat, MD +493514583274 karin.pillunat@uniklinikum-dresden.de
Contact: Cosima Hermann, MD cosima.hermann@uniklinikum-dresden.de

Locations
Germany
University Eye Clinic Dresden Recruiting
Dresden, Germany, 01307
Contact: Karin R Pillunat, MD     +493514583274     karin.pillunat@uniklinikum-dresden.de    
Contact: Cosima Hermann, MD         cosima.hermann@uniklinikum-dresden.de    
Sponsors and Collaborators
Dresden University of Technology
Investigators
Principal Investigator: Karin R Pillunat, MD University Eye Clinic Dresden
  More Information

No publications provided

Responsible Party: Dresden University of Technology
ClinicalTrials.gov Identifier: NCT01503996     History of Changes
Other Study ID Numbers: Drinking/Glaucoma
Study First Received: December 1, 2011
Last Updated: January 2, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Dresden University of Technology:
dehydration
risk factor
glaucoma
Controls

Additional relevant MeSH terms:
Dehydration
Glaucoma
Water-Electrolyte Imbalance
Metabolic Diseases
 Pathologic Processes
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on May 21, 2013