Reproducibility of RNFL and ONH Measurements in OAG With Heidelberg Spectralis SD-OCT Glaucoma Module Premium Edition
NCT ID: NCT02247284
Last Updated: 2020-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2015-03-01
2019-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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).
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Jens Funk, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UniversityHospital Zurich, Zurich, Switzerland
Locations
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UniversityHospital Zurich
Zurich, Canton of Zurich, Switzerland
Countries
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Other Identifiers
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Glaucoma-Premium-OCT
Identifier Type: -
Identifier Source: org_study_id
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