Primary Open Angle Glaucoma Clinical Trial
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.
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.
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