NCT01503996

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 4, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 30, 2015

Status Verified

November 1, 2015

Enrollment Period

4 years

First QC Date

December 1, 2011

Last Update Submit

November 26, 2015

Conditions

DehydrationGlaucoma

Keywords

dehydrationrisk factorglaucomaControls

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • microvascular changes

    4 years

Study Arms (2)

glaucoma

hospitalized glaucoma patients

Behavioral: alter drinking habits

controls

hospitalized patients without glaucoma

Behavioral: alter drinking habits

Interventions

alter drinking habitsBEHAVIORAL

if dehydration is apparent, more fluid intake is recommended

controlsglaucoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • glaucoma patients
  • controls

You may not qualify if:

  • psychiatric disease,
  • epilepsy, pregnancy,
  • nutritional disorder,
  • malfunction of blood clotting and wound healing,
  • pacemaker,
  • metallic stents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye Clinic Dresden

Dresden, 01307, Germany

Location

Related Publications (1)

  • 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.

    PMID: 24820045DERIVED

MeSH Terms

Conditions

DehydrationGlaucoma

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsOcular HypertensionEye Diseases

Study Officials

  • Karin R Pillunat, MD

    University Eye Clinic Dresden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

December 1, 2011

First Posted

January 4, 2012

Study Start

October 1, 2011

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

November 30, 2015

Record last verified: 2015-11

Locations

DE(1)