Reproducibility of Cirrus Optical Coherence Tomography Measurements

NCT00643422 | Completed

• 1 other identifier: Cirrus_OCT_0308
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

normal eyes

Outcome Measures

Primary Outcomes (1)

• retinal thickness

  two

Secondary Outcomes (1)

• retinal volume

  two

Study Arms (1)

Observation

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

Interventions

Cirrus™ HD-OCT, Carl Zeiss Meditec AG DEVICE

the retinal thickness and volume is determined on two different days with the Cirrus™ HD-OCT.

Observation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

attendants of health care center

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery: lead

Study Sites (1)

Rudolf Foundation Clinic

Vienna, 1030, Austria

Location

Related Publications (9)

• 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. doi: 10.1016/j.ajo.2006.11.042. Epub 2006 Dec 22.

  PMID: 17317392 BACKGROUND

• 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. doi: 10.1167/iovs.03-0514.

  PMID: 15161831 BACKGROUND

• 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. doi: 10.1001/archopht.123.10.1330.

  PMID: 16219723 BACKGROUND

• 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. doi: 10.1001/archopht.126.1.45.

  PMID: 18195217 BACKGROUND

• 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. doi: 10.1016/j.ophtha.2005.12.020. Epub 2006 May 2.

  PMID: 16647123 BACKGROUND

• Budenz DL, Fredette MJ, Feuer WJ, Anderson DR. Reproducibility of peripapillary retinal nerve fiber thickness measurements with stratus OCT in glaucomatous eyes. Ophthalmology. 2008 Apr;115(4):661-666.e4. doi: 10.1016/j.ophtha.2007.05.035. Epub 2007 Aug 13.

  PMID: 17706287 BACKGROUND

• 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. doi: 10.1097/IJG.0b013e31811243b4.

  PMID: 18303381 BACKGROUND

• 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. doi: 10.1016/j.ophtha.2006.10.055. Epub 2007 Mar 13.

  PMID: 17353052 BACKGROUND

• Hagen S, Krebs I, Haas P, Glittenberg C, Falkner-Radler CI, Graf A, Ansari-Shahrezaei S, Binder S. Reproducibility and comparison of retinal thickness and volume measurements in normal eyes determined with two different Cirrus OCT scanning protocols. Retina. 2011 Jan;31(1):41-7. doi: 10.1097/IAE.0b013e3181dde71e.

  PMID: 20838360 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 22, 2008
• First Posted: March 26, 2008
• Last Updated: July 22, 2008

Record last verified: 2008-07

Locations

AU (1)