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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00643422
Other study ID # Cirrus_OCT_0308
Secondary ID
Status Completed
Phase N/A
First received March 22, 2008
Last updated July 21, 2008

Study information

Verified date July 2008
Source The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
Cirrus™ HD-OCT, Carl Zeiss Meditec AG
the retinal thickness and volume is determined on two different days with the Cirrus™ HD-OCT.

Locations

Country Name City State
Austria Rudolf Foundation Clinic Vienna

Sponsors (1)

Lead Sponsor Collaborator
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Country where clinical trial is conducted

Austria, 

References & Publications (8)

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. Epub 2007 Aug 13. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary retinal thickness two No
Secondary retinal volume two No
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