Reproducibility of RNFL and ONH Measurements in OAG With Heidelberg Spectralis SD-OCT Glaucoma Module Premium Edition

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Primary Open Angle Glaucoma

Intervention / Treatment
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* Device: RNFL and BMO-MRW SD-OCT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group 1<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | baseline and 3 months +/- 1 month |