Drinking Habits of Glaucoma Patients and Age Matched Controls

Glaucoma Clinical Trial

Official title:

Clinical Study to Evaluate the Drinking Habits of Glaucoma Patients and Age Matched Controls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01503996
• Other study ID #: Drinking/Glaucoma
• Status: Completed
• Phase: N/A
• First received: December 1, 2011
• Last updated: November 26, 2015
• Start date: October 2011
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• glaucoma patients

• controls

Exclusion Criteria:

• psychiatric disease,

• epilepsy, pregnancy,

• nutritional disorder,

• malfunction of blood clotting and wound healing,

• pacemaker,

• metallic stents

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dehydration
• Glaucoma

Intervention

Behavioral:
• alter drinking habits
if dehydration is apparent, more fluid intake is recommended

Locations

Country	Name	City	State
Germany	University Eye Clinic Dresden	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dehydration	The composition of a patient's body, in particular a patient's water content are determined with bioimpedance spectroscopy (Body Composition Monitor, FRESENIUS)	4 years	No
Secondary	microvascular changes	To investigate differences in retinal vessel diameters measured with the Retinal Vessel Analyzer (RVA, IMEDOS) in glaucoma patients and controls	4 years	No