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

Primary Open Angle Glaucoma Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02247284
• Other study ID #: Glaucoma-Premium-OCT
• Status: Completed
• Phase: N/A
• Start date: March 1, 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma

Intervention

Device:
• RNFL 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).

Locations

Country	Name	City	State
Switzerland	UniversityHospital Zurich	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal nerve fiber layer thickness (RNFL)	Retinal nerve fiber layer thickness (RNFL) measured with Spectralis OCT	baseline and 3 months +/- 1 month
Primary	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	Coefficient of variations (COV) of RNFL and BMO-MRW	Coefficient of variations (COV) of RNFL and BMO-MRW	baseline and 3 months +/- 1 month
Secondary	Intra-class-correlations (ICC) of RNFL and BMO-MRW	Intra-class-correlations (ICC) of RNFL and BMO-MRW	baseline and 3 months +/- 1 month