This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Choroidal Thickness in Glaucoma Patients and Healthy Controls

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University of Zurich.
Recruitment status was:  Enrolling by invitation
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01293474
First received: February 9, 2011
Last updated: January 5, 2015
Last verified: December 2014
  Purpose

With the new software tool (EDI, enhanced depth imaging) of the Spectralis® spectral-domain optical coherence tomography (SD-OCT) it is possible to visualize and measure the choroidal thickness. In glaucoma a vascular component is known. Therefore a difference of choroidal thickness in glaucoma patients and healthy controls is proposed.

  • Trial with medical device

Condition Intervention Phase
Glaucoma Patients and Healthy Controls Device: Spectralis® SD-OCT, Heidelberg Engineering GmbH, H Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • COV [ Time Frame: t0 ]

Estimated Enrollment: 200
Study Start Date: February 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
glaucoma patients
patients with diagnosis of primary open angle glaucoma
Device: Spectralis® SD-OCT, Heidelberg Engineering GmbH, H
Measurement of the choroidal thickness with Spectralis® SD-OCT
control group
age matched healthy controls
Device: Spectralis® SD-OCT, Heidelberg Engineering GmbH, H
Measurement of the choroidal thickness with Spectralis® SD-OCT

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients and controls are selected out of our primary care clinic
Criteria

Inclusion criteria: for both groups (glaucoma study group and control group):

men and women of at least 50 years of age

for the glaucoma study group: diagnosis of primary open angle glaucoma (POAG)

Exclusion criteria: for both groups (glaucoma study group and control group):

  • less then 50 years of age
  • any pathology of the central retina
  • any optic nerve disorder other then glaucoma
  • retinal vascular disorder

for the glaucoma study group: other glaucoma diagnosis then primary open angle glaucoma

for the control group: any diagnosis of glaucoma

  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: NCT01293474

Locations
Switzerland
University Hospital Zurich, Ophthalmic Clinic
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Christoph Kniestedt, Ass. Prof., MD University Hospital Zurich, Ophtalmic Clinic
  More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01293474     History of Changes
Other Study ID Numbers: EDI-OCT
Study First Received: February 9, 2011
Last Updated: January 5, 2015

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on June 26, 2017