Trial record 9 of 23 for:    Open Studies | "Dehydration"

Drinking Habits of Glaucoma Patients and Age Matched Controls

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Technische Universität Dresden
Sponsor:
Information provided by (Responsible Party):
Dr. Karin Pillunat, Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT01503996
First received: December 1, 2011
Last updated: October 6, 2013
Last verified: October 2013
  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:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • Dehydration [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    The composition of a patient's body, in particular a patient's water content are determined with bioimpedance spectroscopy (Body Composition Monitor, FRESENIUS)


Secondary Outcome Measures:
  • microvascular changes [ Time Frame: 4 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 2016
Estimated Primary Completion Date: October 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Technische Universität Dresden
Investigators
Principal Investigator: Karin R Pillunat, MD University Eye Clinic Dresden
  More Information

No publications provided

Responsible Party: Dr. Karin Pillunat, Dr. med., Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT01503996     History of Changes
Other Study ID Numbers: Drinking/Glaucoma
Study First Received: December 1, 2011
Last Updated: October 6, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität Dresden:
dehydration
risk factor
glaucoma
Controls

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

ClinicalTrials.gov processed this record on September 16, 2014