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

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

Study Overview

• Status: Unknown
• Conditions: Glaucoma Patients and Healthy Controls
• Intervention / Treatment: Device: Spectralis® SD-OCT, Heidelberg Engineering GmbH, H

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • University Hospital Zurich, Ophthalmic Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients and controls are selected out of our primary care clinic

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
control group; age matched healthy controls	Device: Spectralis® SD-OCT, Heidelberg Engineering GmbH, H; Measurement of the peripapillar nerve fiber layer with different settings of ART
Glaucoma; patients with diagnosis of primary open angle glaucoma	Device: Spectralis® SD-OCT, Heidelberg Engineering GmbH, H; Measurement of the peripapillar nerve fiber layer with different settings of ART

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
COV	T0

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: February 16, 2011
• First Submitted That Met QC Criteria: February 17, 2011
• First Posted (Estimate): February 18, 2011

Study Record Updates

• Last Update Posted (Estimate): January 6, 2015
• Last Update Submitted That Met QC Criteria: January 5, 2015
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: ART-OCT