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Completed

NCT Number: NCT02247284

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UniversityHospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Retinal nerve fiber layer thickness (RNFL)

    Time frame: baseline and 3 months +/- 1 month

    Retinal nerve fiber layer thickness (RNFL) measured with Spectralis OCT

  2. Bruch's membrane opening-based minimum rim width (BMO-MRW)

    Time frame: baseline and 3 months +/- 1 month

    Bruch's membrane opening-based minimum rim width (BMO-MRW) measured with Spectralis OCT

Secondary outcomes

  1. Coefficient of variations (COV) of RNFL and BMO-MRW

    Time frame: baseline and 3 months +/- 1 month

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

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

    Time frame: baseline and 3 months +/- 1 month

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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 25, 2014
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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