Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RNFL and BMO-MRW SD-OCT | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Retinal nerve fiber layer thickness (RNFL) | Retinal nerve fiber layer thickness (RNFL) measured with Spectralis OCT | 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 | baseline and 3 months +/- 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Coefficient of variations (COV) of RNFL and BMO-MRW | Coefficient of variations (COV) of RNFL and BMO-MRW | baseline and 3 months +/- 1 month |
| Intra-class-correlations (ICC) of RNFL and BMO-MRW | Intra-class-correlations (ICC) of RNFL and BMO-MRW |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jens Funk, MD, PhD | UniversityHospital Zurich, Zurich, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UniversityHospital Zurich | Zurich | Canton of Zurich | 8091 | Switzerland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| baseline and 3 months +/- 1 month |