Reproducibility of RNFL and ONH Measurements in OAG With Heidelberg Spectralis SD-OCT Glaucoma Module Premium Edition
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|ClinicalTrials.gov Identifier: NCT02247284|
Recruitment Status : Recruiting
First Posted : September 25, 2014
Last Update Posted : June 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Primary Open Angle Glaucoma||Device: RNFL and BMO-MRW SD-OCT||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||March 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
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).
- Retinal nerve fiber layer thickness (RNFL) [ Time Frame: baseline and 3 months +/- 1 month ]Retinal nerve fiber layer thickness (RNFL) measured with Spectralis OCT
- Bruch's membrane opening-based minimum rim width (BMO-MRW) [ Time Frame: baseline and 3 months +/- 1 month ]Bruch's membrane opening-based minimum rim width (BMO-MRW) measured with Spectralis OCT
- Coefficient of variations (COV) of RNFL and BMO-MRW [ Time Frame: baseline and 3 months +/- 1 month ]Coefficient of variations (COV) of RNFL and BMO-MRW
- Intra-class-correlations (ICC) of RNFL and BMO-MRW [ Time Frame: baseline and 3 months +/- 1 month ]Intra-class-correlations (ICC) of RNFL and BMO-MRW
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247284
|Contact: Jens Funk, MD, PhD||+41 255 1111|
|Zurich, ZH, Switzerland, 8091|
|Contact: Jens Funk, MD, PhD +41 44 255 1111|
|Sub-Investigator: Marc Toeteberg-Harms, MD, FEBO|
|Principal Investigator:||Jens Funk, MD, PhD||UniversityHospital Zurich, Zurich, Switzerland|