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Reproducibility of RNFL and ONH Measurements in OAG With Heidelberg Spectralis SD-OCT Glaucoma Module Premium Edition
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Purpose
| Condition | Intervention |
|---|---|
| Primary Open Angle Glaucoma | Device: RNFL and BMO-MRW SD-OCT |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Diagnostic |
| Official 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. |
- Retinal nerve fiber layer thickness (RNFL) [ Time Frame: baseline and 3 months +/- 1 month ]Retinal nerve fiber layer thickness (RNFL) measured with Spectralis OCT
- 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
- 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
- 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
| Estimated Enrollment: | 50 |
| Study Start Date: | March 2015 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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).
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT02247284
| Contact: Jens Funk, MD, PhD | +41 255 1111 |
| Switzerland | |
| UniversityHospital Zurich | Recruiting |
| Zurich, ZH, Switzerland, 8091 | |
| Contact: Jens Funk, MD, PhD +41 44 255 1111 | |
| Sub-Investigator: Marc Toeteberg-Harms, MD, FEBO | |
| Principal Investigator: | Jens Funk, MD, PhD | UniversityHospital Zurich, Zurich, Switzerland |
More Information
| Responsible Party: | University of Zurich |
| ClinicalTrials.gov Identifier: | NCT02247284 History of Changes |
| Other Study ID Numbers: |
Glaucoma-Premium-OCT |
| Study First Received: | September 16, 2014 |
| Last Updated: | June 19, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle Ocular Hypertension Eye Diseases |
ClinicalTrials.gov processed this record on July 24, 2017