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

NCT02247284 | Completed

• 1 other identifier: Glaucoma-Premium-OCT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Open Angle Glaucoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Coefficient of variations (COV) of RNFL and BMO-MRW

  baseline and 3 months +/- 1 month

• Intra-class-correlations (ICC) of RNFL and BMO-MRW

  baseline and 3 months +/- 1 month

Study Arms (1)

group 1

EXPERIMENTAL

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

Interventions

RNFL and BMO-MRW SD-OCT DEVICE

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).

group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

UniversityHospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Jens Funk, MD, PhD

  UniversityHospital Zurich, Zurich, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: September 25, 2014
• Study Start: March 1, 2015
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)