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Reproducibility of RNFL and ONH Measurements in OAG With Heidelberg Spectralis SD-OCT Glaucoma Module Premium Edition

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT02247284
First received: September 16, 2014
Last updated: April 29, 2015
Last verified: April 2015
History of Changes
  Purpose
The purpose of this study is to assess and compare the repeatability of SD-OCT (Spectralis™ OCT, Version 6.0, Heidelberg Engineering, Germany) RNFL thickness measurements with a new software (glaucoma premium module) with the well established peripapillary RNFL thickness measurements in patients with primary open angle glaucoma.

Condition Intervention
Primary Open Angle Glaucoma
 Device: RNFL and BMO-MRW SD-OCT

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Study to Investigate Reproducibility of the New Heidelberg Spectralis SD-OCT Glaucoma Module Premium Edition (Software Version 6.0) in Comparison to Reproducibility of RNFL Scans.

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Retinal nerve fiber layer thickness (RNFL) [ Time Frame: baseline and 3 months +/- 1 month ] [ Designated as safety issue: No ]
  • Bruch's membrane opening-based minimum rim width (BMO-MRW) [ Time Frame: baseline and 3 months +/- 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Coefficient of variations (COV) of RNFL and BMO-MRW [ Time Frame: baseline and 3 months +/- 1 month ] [ Designated as safety issue: No ]
  • Intra-class-correlations (ICC) of RNFL and BMO-MRW [ Time Frame: baseline and 3 months +/- 1 month ] [ Designated as safety issue: No ]
Estimated Enrollment: 50
Study Start Date: March 2015
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group 1
patient with a diagnosis of primary open angle glaucoma will undergo 'RNFL and BMO-MRW SD-OCT' measurements with Heidelberg Spectralis SD-OCT old protocoll and Glaucoma Premium Module (new) protocoll, which in addition to RNFL measurements include measurement of Bruch's Membrane Opening-based minimum rim width (BMO-MRW).
 Device: RNFL and BMO-MRW SD-OCT
Masurement of peripapillary RNFL measurements with Heidelberg Spectralis SD-OCT (Heidelberg Engeneering GmbH, Heidelberg, Germany) old protocoll and in addition with the new Glaucoma Premium Module (software version 6.0) tocoll, which in addition to RNFL measurements include measurement of Bruch's Membrane Opening-based minimum rim width (BMO-MRW).

Detailed Description:

The purpose of this study is to assess and compare the repeatability of SD-OCT (Spectralis™ OCT, Version 6.0, Heidelberg Engineering, Germany) RNFL thickness measurements with the new software (method B) and with the previous method of measurement (method A) in patients with glaucoma.

It is a prospective, not blinded, not randomised, monocentric study. Inclusion of 50 patients with a diagnosis of primary open angle glaucoma (POAG), that will be recruited from the ophthalmology outpatient department of the UniversityHospital Zurich, Switzerland. All patients will undergo a full ophthalmic examination including measurement of refraction, best corrected visual acuity, examination of anterior and posterior compartment and measurement of the intraocular pressure. On the same day they will have 3 OCT examinations with a new method of measurement (method B).On the same day the first 10 patients will undergo also 3 OCT examinations with the previous method (method A) and they will get an other 3 OCT examinations with method B by a second observer. For this 10 patients the next consultation (3 months +/- 1 month) the 3 OCT examinations with method B will be repeated by the first observer.

Primary objectives are coefficient of variations (COV) of method A and B; Intra-class-correlations (ICC) of method A and B.

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of POAG glaucoma
  • male and female patients aged 18 years or older, no upper limit
  • written informed consent
  • visual acuity of more or equal to 0.5 Snellen
  • refractive error between + /- 6.00 D spheric and under or equal than 2.00 D cylindrical

Exclusion Criteria:

  • history of surgery other than uncomplicated cataract surgery
  • disease affecting cornea, anterior compartment, lens, vitreous body
  • history of severe ocular disease, particularly diseases affecting the optic nerve, other than glaucoma
  • history of ocular trauma
  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: NCT02247284

Contacts
Contact: Jens Funk, MD, PhD +41 255 1111

Locations
Switzerland
UniversityHospital Zurich Recruiting
Zurich, ZH, Switzerland, 8091
Contact: Jens Funk, MD, PhD    +41 44 255 1111      
Sub-Investigator: Marc Toeteberg-Harms, MD, FEBO         
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Jens Funk, MD, PhD UniversityHospital Zurich, Zurich, Switzerland
  More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02247284     History of Changes
Other Study ID Numbers: Glaucoma-Premium-OCT 
Study First Received: September 16, 2014
Last Updated: April 29, 2015
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on September 26, 2016