Choroidal Thickness in Glaucoma Patients and Healthy Controls

Glaucoma Patients and Healthy Controls Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01293474
• Other study ID #: EDI-OCT
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: February 9, 2011
• Last updated: January 5, 2015
• Start date: February 2011
• Est. completion date: December 2015

Study information

• Verified date: December 2014
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma Patients and Healthy Controls

Intervention

Device:
• Spectralis® SD-OCT, Heidelberg Engineering GmbH, H
Measurement of the choroidal thickness with Spectralis® SD-OCT

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Ophthalmic Clinic	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COV		t0	No