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

Not Applicable

Completed

• Conditions: Primary Open Angle Glaucoma
• Interventions: Device: RNFL and BMO-MRW SD-OCT

• Registration Number: NCT02247284
• Lead Sponsor: University of Zurich

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-09-16
• Study First Submitted QC: 2014-09-18
• Study First Posted: 2014-09-25
• Study Start: 2015-03-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
group 1	RNFL and BMO-MRW SD-OCT	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).

Primary Outcome Measures

Name	Time	Method
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
Retinal nerve fiber layer thickness (RNFL)	baseline and 3 months +/- 1 month	Retinal nerve fiber layer thickness (RNFL) measured with Spectralis OCT

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UniversityHospital Zurich; 🇨🇭 Zurich, ZH, Switzerland