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
  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:


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
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: 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

ClinicalTrials.gov processed this record on September 22, 2014