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

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.

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.

Study Overview

• Status: Completed
• Conditions: Primary Open Angle Glaucoma
• Intervention / Treatment: Device: RNFL and BMO-MRW SD-OCT

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • UniversityHospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group 1; 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; 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Jens Funk, MD, PhD, UniversityHospital Zurich, Zurich, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: September 16, 2014
• First Submitted That Met QC Criteria: September 18, 2014
• First Posted (Estimate): September 25, 2014

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: Glaucoma-Premium-OCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No