Reproducibility of RNFL Circle Scans With ART-Function of Heidelberg Spectralis SD-OCT Software Version 5.3

Glaucoma Patients and Healthy Controls Clinical Trial

Official title:

Reproducibility of RNFL Circle Scans With ART-Function of Heidelberg Spectralis SD-OCT Software Version 5.3

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01299233
• Other study ID #: ART-OCT
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: February 16, 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

To assess the improvement in reproducibility of 100 vs. 16 averaged images by Automatic Real Time (ART) using Spectralis™ Spectral Domain-Optical Coherence Tomography (SD-OCT, Heidelberg Engineering GmbH, Heidelberg, Germany) in retinal nerve fiber layer thickness (RNFL) circle scan-measurements.

• Trial with medical device

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 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 18 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 Patients and Healthy Controls

Intervention

Device:
• Spectralis® SD-OCT, Heidelberg Engineering GmbH, H
Measurement of the peripapillar nerve fiber layer with different settings of ART

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