An interventional study of RNFL and BMO-MRW SD-OCT in Primary Open Angle Glaucoma, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-25.
Sponsored by University of Zurich · Not applicable, Interventional, and Diagnostic
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.
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.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 50 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.
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Exclusion Criteria:
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)
Retinal nerve fiber layer thickness (RNFL) measured with Spectralis OCT
Time frame: baseline and 3 months +/- 1 month
Bruch's membrane opening-based minimum rim width (BMO-MRW)
Bruch's membrane opening-based minimum rim width (BMO-MRW) measured with Spectralis OCT
Time frame: baseline and 3 months +/- 1 month
Coefficient of variations (COV) of RNFL and BMO-MRW
Coefficient of variations (COV) of RNFL and BMO-MRW
Time frame: baseline and 3 months +/- 1 month
Intra-class-correlations (ICC) of RNFL and BMO-MRW
Intra-class-correlations (ICC) of RNFL and BMO-MRW
Time frame: baseline and 3 months +/- 1 month
Plan to share: No
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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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University of Zurich