Back to resultsReproducibility of Retinal Nerve Fiber Layer Thickness Measurements Using the Eye Tracker and Retest Function of Spectralis® SD-OCT in Glaucomatous Eyes and Healthy Controls
Primary Purpose
Glaucoma
Status
Terminated
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Spectralis® SD-OCT, Heidelberg Engineering GmbH, H
Sponsored by
About this trial
This is an interventional diagnostic trial for Glaucoma
Eligibility Criteria
Inclusion criteria:
- Visual acuity of more or equal to 0.5 Snellen, refractive error less than ±5.00 diopters (D) spheric and ±3.00 D cylindrical and no history of ocular trauma or of any other severe ocular disease (particularly diseases affecting the optic nerve or surgery other than uncomplicated cataract surgery).
- Additional inclusion criteria for the glaucoma group were a diagnosis of primary open angle glaucoma (POAG) or PEX-glaucoma.
Exclusion criteria:
- Exclusion criteria for the control group were history of glaucoma or intraocular pressure beyond 21 mmHg and optic disc cupping of more than 0.6
Sites / Locations
Outcomes
Primary Outcome Measures
retinal nerve fiber layer thickness measurement
Secondary Outcome Measures
Full Information
NCT ID
NCT01228721
First Posted
October 25, 2010
Last Updated
October 25, 2010
Sponsor
University of Zurich
1. Study Identification
Unique Protocol Identification Number
NCT01228721
Brief Title
Reproducibility of Retinal Nerve Fiber Layer Thickness Measurements Using the Eye Tracker and Retest Function of Spectralis® SD-OCT in Glaucomatous Eyes and Healthy Controls
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Terminated
Study Start Date
January 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2010 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Zurich
4. Oversight
5. Study Description
Brief Summary
PURPOSE. To evaluate the impact of self-acting eyetracking and retest software on the reproducibility of retinal nerve fiber layer (RNFL) thickness measurements in glaucoma patients and healthy control subjects using Spectralis® SD-OCT.
METHODS. RNFL thickness was measured in 56 normal and 47 glaucomatous eyes by one operator within one session with a brief rest between measurements. Three measurements were taken with the eye-tracker and retest function, and three were taken without this function, alternating between measurement methods.
Trial with medical device
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Spectralis® SD-OCT, Heidelberg Engineering GmbH, H
Primary Outcome Measure Information:
Title
retinal nerve fiber layer thickness measurement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Visual acuity of more or equal to 0.5 Snellen, refractive error less than ±5.00 diopters (D) spheric and ±3.00 D cylindrical and no history of ocular trauma or of any other severe ocular disease (particularly diseases affecting the optic nerve or surgery other than uncomplicated cataract surgery).
Additional inclusion criteria for the glaucoma group were a diagnosis of primary open angle glaucoma (POAG) or PEX-glaucoma.
Exclusion criteria:
Exclusion criteria for the control group were history of glaucoma or intraocular pressure beyond 21 mmHg and optic disc cupping of more than 0.6
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
01 Studienregister MasterAdmins
Organizational Affiliation
UniversitaetsSpital Zuerich
Official's Role
Study Director
Facility Information:
City
Zurich
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
21330656
Citation
Langenegger SJ, Funk J, Toteberg-Harms M. Reproducibility of retinal nerve fiber layer thickness measurements using the eye tracker and the retest function of Spectralis SD-OCT in glaucomatous and healthy control eyes. Invest Ophthalmol Vis Sci. 2011 May 18;52(6):3338-44. doi: 10.1167/iovs.10-6611.
Results Reference
derived
Learn more about this trial
Reproducibility of Retinal Nerve Fiber Layer Thickness Measurements Using the Eye Tracker and Retest Function of Spectralis® SD-OCT in Glaucomatous Eyes and Healthy Controls
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