Reproducibility of RNFL and ONH Measurements in OAG With Heidelberg Spectralis SD-OCT Glaucoma Module Premium Edition
Primary Purpose
Primary Open Angle Glaucoma
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
RNFL and BMO-MRW SD-OCT
Sponsored by
About this trial
This is an interventional diagnostic trial for Primary Open Angle Glaucoma
Eligibility 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
Sites / Locations
- UniversityHospital Zurich
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
group 1
Arm Description
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).
Outcomes
Primary Outcome Measures
Retinal nerve fiber layer thickness (RNFL)
Retinal nerve fiber layer thickness (RNFL) measured with Spectralis OCT
Bruch's membrane opening-based minimum rim width (BMO-MRW)
Bruch's membrane opening-based minimum rim width (BMO-MRW) measured with Spectralis OCT
Secondary Outcome Measures
Coefficient of variations (COV) of RNFL and BMO-MRW
Coefficient of variations (COV) of RNFL and BMO-MRW
Intra-class-correlations (ICC) of RNFL and BMO-MRW
Intra-class-correlations (ICC) of RNFL and BMO-MRW
Full Information
NCT ID
NCT02247284
First Posted
September 16, 2014
Last Updated
March 24, 2020
Sponsor
University of Zurich
1. Study Identification
Unique Protocol Identification Number
NCT02247284
Brief Title
Reproducibility of RNFL and ONH Measurements in OAG With Heidelberg Spectralis SD-OCT Glaucoma Module Premium Edition
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
RNFL and BMO-MRW SD-OCT
Intervention Description
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).
Primary Outcome Measure Information:
Title
Retinal nerve fiber layer thickness (RNFL)
Description
Retinal nerve fiber layer thickness (RNFL) measured with Spectralis OCT
Time Frame
baseline and 3 months +/- 1 month
Title
Bruch's membrane opening-based minimum rim width (BMO-MRW)
Description
Bruch's membrane opening-based minimum rim width (BMO-MRW) measured with Spectralis OCT
Time Frame
baseline and 3 months +/- 1 month
Secondary Outcome Measure Information:
Title
Coefficient of variations (COV) of RNFL and BMO-MRW
Description
Coefficient of variations (COV) of RNFL and BMO-MRW
Time Frame
baseline and 3 months +/- 1 month
Title
Intra-class-correlations (ICC) of RNFL and BMO-MRW
Description
Intra-class-correlations (ICC) of RNFL and BMO-MRW
Time Frame
baseline and 3 months +/- 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Funk, MD, PhD
Organizational Affiliation
UniversityHospital Zurich, Zurich, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
UniversityHospital Zurich
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Reproducibility of RNFL and ONH Measurements in OAG With Heidelberg Spectralis SD-OCT Glaucoma Module Premium Edition
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