Primary Open Angle Glaucoma
Conditions
Brief 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.
Detailed 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.
Interventions
DEVICERNFL 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).
Sponsors
University of Zurich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of POAG glaucoma * male and female patients aged 18 years or older, no upper limit * written informed consent * visual acuity of more or equal to 0.5 Snellen * refractive error between + /- 6.00 D spheric and under or equal than 2.00 D cylindrical
Exclusion criteria
* history of surgery other than uncomplicated cataract surgery * disease affecting cornea, anterior compartment, lens, vitreous body * history of severe ocular disease, particularly diseases affecting the optic nerve, other than glaucoma * history of ocular trauma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retinal nerve fiber layer thickness (RNFL) | 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) | baseline and 3 months +/- 1 month | Bruch's membrane opening-based minimum rim width (BMO-MRW) measured with Spectralis OCT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Coefficient of variations (COV) of RNFL and BMO-MRW | baseline and 3 months +/- 1 month | Coefficient of variations (COV) of RNFL and BMO-MRW |
| Intra-class-correlations (ICC) of RNFL and BMO-MRW | baseline and 3 months +/- 1 month | Intra-class-correlations (ICC) of RNFL and BMO-MRW |
Countries
Switzerland
Outcome results
None listed