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TerminatedNCT01273285Updated Jan 10, 2011

Reproducibility of Nerve Fiber Layer Thickness Measurements in Patients With Glaucoma and Healthy Controls Using Spectral-Domain and Time-Domain OCT

A Phase 4 interventional study of Spectralis® SD-OCT, Heidelberg Engineering GmbH, H in Glaucoma Patients and Healthy Controls, sponsored by University of Zurich. Terminated at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-01-10.

Sponsored by University of Zurich · Phase 4, Interventional, and Diagnostic

Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study summary

To assess the reproducibility of Spectral-Domain-OCT (SD-OCT) retinal nerve fiber layer thickness (RNFL) thickness measurements in healthy volunteers and patients with glaucoma and to compare these results to conventional Time-Domain-OCT (TD-OCT).

  • Trial with medical device
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Conditions studied

  • Glaucoma Patients and Healthy Controls

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03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 50 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

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Lead sponsor

University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion criteria: control group:

age 18yo or older, healthy

glaucom group: age 18yo or older, diagnosis of primary open angle glaucoma (POAG)

Exclusion criteria: Exclusion criteria in the control group were history of glaucoma, history of any other ocular disease, or intraocular pressure greater than 21mmHg. Exclusion criteria in the glaucoma group were history of other optic neuropathies.

or severe optic media opacities.

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Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Interventions

  • DeviceSpectralis® SD-OCT, Heidelberg Engineering GmbH, H
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What researchers measure

Primary outcomes

  1. reproducibility of retinal nerve fiber layer thickness measurement

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Study locations

1 site
  • Zurich, Switzerland
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References and documents

Publications

  • Toteberg-Harms M, Sturm V, Knecht PB, Funk J, Menke MN. Repeatability of nerve fiber layer thickness measurements in patients with glaucoma and without glaucoma using spectral-domain and time-domain OCT. Graefes Arch Clin Exp Ophthalmol. 2012 Feb;250(2):279-87. doi: 10.1007/s00417-011-1811-9. Epub 2011 Sep 10. PubMed 21909812 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01273285
Lead sponsor
University of Zurich
First posted
Jan 10, 2011
Start date
Apr 2009
Primary completion
Mar 2010
Last update
Jan 10, 2011

Study contacts

01 Studienregister MasterAdmins
study director · UniversitaetsSpital Zuerich
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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