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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02247284
Study type Interventional
Source University of Zurich
Contact
Status Completed
Phase N/A
Start date March 1, 2015
Completion date December 31, 2019

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