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Reproducibility of Cirrus Optical Coherence Tomography Measurements
This study has been completed.
First Received: March 22, 2008   Last Updated: July 21, 2008   History of Changes
Sponsored by: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Information provided by: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier: NCT00643422
  Purpose

In this study the reproducibility of optical coherence tomography measurements should be evaluated.


Condition Intervention
Healthy
 Device: Cirrus™ HD-OCT, Carl Zeiss Meditec AG

U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Reproducibility of Retinal Thickness and Volume Measurements Determined With the Cirrus Spectral Domain OCT

Further study details as provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:

Primary Outcome Measures:
  • retinal thickness [ Time Frame: two ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • retinal volume [ Time Frame: two ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 16
Groups/Cohorts Assigned Interventions
Observation Device: Cirrus™ HD-OCT, Carl Zeiss Meditec AG
the retinal thickness and volume is determined on two different days with the Cirrus™ HD-OCT.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

attendants of health care center

Criteria

Inclusion Criteria:

  • 18 years of age or older
  • best corrected visual acuity of at least 20/25
  • clear optical media

Exclusion Criteria:

  • any kind of retinal pathology
  • any kind of opacity of optical media
  • any kind of intraocular surgery
  • spherical refraction of more than 5 diopters
  • cylindrical refraction of more than 3 diopters
  • amblyopia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00643422

Locations
Austria
Rudolf Foundation Clinic
Vienna, Austria, 1030
Sponsors and Collaborators
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
  More Information

Publications:
Wang XY, Huynh SC, Burlutsky G, Ip J, Stapleton F, Mitchell P. Reproducibility of and effect of magnification on optical coherence tomography measurements in children. Am J Ophthalmol. 2007 Mar;143(3):484-8. Epub 2006 Dec 22.
Paunescu LA, Schuman JS, Price LL, Stark PC, Beaton S, Ishikawa H, Wollstein G, Fujimoto JG. Reproducibility of nerve fiber thickness, macular thickness, and optic nerve head measurements using StratusOCT. Invest Ophthalmol Vis Sci. 2004 Jun;45(6):1716-24.
Polito A, Del Borrello M, Isola M, Zemella N, Bandello F. Repeatability and reproducibility of fast macular thickness mapping with stratus optical coherence tomography. Arch Ophthalmol. 2005 Oct;123(10):1330-7.
Danis RP, Fisher MR, Lambert E, Goulding A, Wu D, Lee LY. Results and repeatability of retinal thickness measurements from certification submissions. Arch Ophthalmol. 2008 Jan;126(1):45-50.
Sadda SR, Tan O, Walsh AC, Schuman JS, Varma R, Huang D. Automated detection of clinically significant macular edema by grid scanning optical coherence tomography. Ophthalmology. 2006 Jul;113(7):1187.e1-12. Epub 2006 May 2.
Budenz DL, Fredette MJ, Feuer WJ, Anderson DR. Reproducibility of Peripapillary Retinal Nerve Fiber Thickness Measurements with Stratus OCT in Glaucomatous Eyes. Ophthalmology. 2007 Aug 10; [Epub ahead of print]
Hsu SY, Tsai RK. Analysis of retinal nerve fiber layer and macular thickness measurements in healthy Taiwanese individuals using optical coherence tomography (Stratus OCT). J Glaucoma. 2008 Jan-Feb;17(1):30-5.
Diabetic Retinopathy Clinical Research Network; Krzystolik MG, Strauber SF, Aiello LP, Beck RW, Berger BB, Bressler NM, Browning DJ, Chambers RB, Danis RP, Davis MD, Glassman AR, Gonzalez VH, Greenberg PB, Gross JG, Kim JE, Kollman C. Reproducibility of macular thickness and volume using Zeiss optical coherence tomography in patients with diabetic macular edema. Ophthalmology. 2007 Aug;114(8):1520-5. Epub 2007 Mar 13.

Responsible Party: Ludwig Boltzmann Institute of retinology and biomicroscopic laser surgery ( Stefan Hagen, MD )
Study ID Numbers: Cirrus_OCT_0308
Study First Received: March 22, 2008
Last Updated: July 21, 2008
ClinicalTrials.gov Identifier: NCT00643422     History of Changes
Health Authority: Austria: Ethikkommission

Keywords provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:
normal eyes

Study placed in the following topic categories:
Healthy

ClinicalTrials.gov processed this record on May 07, 2009



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