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Reproducibility of Retinal Nerve Fiber Layer (RNFL) Circle Scans With Enhanced Automatic Real Time-Function of Heidelberg Spectralis SD-OCT Software Version 5.3

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01299233
First received: February 16, 2011
Last updated: November 3, 2011
Last verified: November 2011
History of Changes
  Purpose

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

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:

U.S. FDA Resources

Further study details as provided by University of Zurich:

Estimated Enrollment: 100
Study Start Date: February 2011
Estimated Study Completion Date: December 2012
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01299233

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

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01299233     History of Changes
Other Study ID Numbers: ART-OCT
Study First Received: February 16, 2011
Last Updated: November 3, 2011
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on June 18, 2013