NCT01272063|CompletedDMC
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Sponsor study identifier
observational
91
1 country
4
Study Start
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2011
Actual (reported)Study Completion
February 2011
Actual (reported)The objective of this study is to compare the areas designated as elevated retinal pigment epithelium (RPE) by the Cirrus HD-OCT versus those designated as drusen on color fundus photographs (CFPs).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2011
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
January 5, 2011
Actual (reported)January 7, 2011
Actual (reported)February 2011
Actual (reported)February 2011
Actual (reported)To compare area measurements of elevated RPE as observed in the Cirrus HD-OCT versus those designated as drusen on color fundus photographs.
Study was released before December 1, 2012
To describe the clinical factors that affected the automated segmentation of elevated RPE by the Cirrus HD-OCT.
Study was released before December 1, 2012
To describe the qualitative similarities and differences between the areas designated as elevated RPE by the Cirrus HD-OCT versus those designated as drusen on color fundus photographs.
Study was released before December 1, 2012
Patients diagnosed with dry AMD with macular drusen
Primary Care Clinic
East Bay Retina
Oakland, California, 94609, United States
West Coast Retina
San Francisco, California, 94107-1756, United States
Bascom Palmer Eye Institute
Miami, Florida, 33136, United States
TLC Eyecare and Laser Centers
Lansing, Michigan, 48912, United States
Klein R, Cruickshanks KJ, Nash SD, Krantz EM, Nieto FJ, Huang GH, Pankow JS, Klein BE. The prevalence of age-related macular degeneration and associated risk factors. Arch Ophthalmol. 2010 Jun;128(6):750-8. doi: 10.1001/archophthalmol.2010.92.
Varma R, Foong AW, Lai MY, Choudhury F, Klein R, Azen SP; Los Angeles Latino Eye Study Group. Four-year incidence and progression of age-related macular degeneration: the Los Angeles Latino Eye Study. Am J Ophthalmol. 2010 May;149(5):741-51. doi: 10.1016/j.ajo.2010.01.009.
Philip Rosenfeld, MD
Bascom Palmer Eye Institute
Carmelina Gordon, MD
TLC Eyecare and Laser Center
Eugene Lit, MD
East Bay Retina Consultants
Brandon Lujan, MD
West Coast Retina
91 participants (actual enrollment reported by the registry).
First Submitted
January 5, 2011
First Posted
January 7, 2011
Study Start
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Yi K, Mujat M, Park BH, Sun W, Miller JW, Seddon JM, Young LH, de Boer JF, Chen TC. Spectral domain optical coherence tomography for quantitative evaluation of drusen and associated structural changes in non-neovascular age-related macular degeneration. Br J Ophthalmol. 2009 Feb;93(2):176-81. doi: 10.1136/bjo.2008.137356. Epub 2008 Aug 12.
Jain N, Farsiu S, Khanifar AA, Bearelly S, Smith RT, Izatt JA, Toth CA. Quantitative comparison of drusen segmented on SD-OCT versus drusen delineated on color fundus photographs. Invest Ophthalmol Vis Sci. 2010 Oct;51(10):4875-83. doi: 10.1167/iovs.09-4962. Epub 2010 Apr 14.
Stopa M, Bower BA, Davies E, Izatt JA, Toth CA. Correlation of pathologic features in spectral domain optical coherence tomography with conventional retinal studies. Retina. 2008 Feb;28(2):298-308. doi: 10.1097/IAE.0b013e3181567798.
Ahlers C, Gotzinger E, Pircher M, Golbaz I, Prager F, Schutze C, Baumann B, Hitzenberger CK, Schmidt-Erfurth U. Imaging of the retinal pigment epithelium in age-related macular degeneration using polarization-sensitive optical coherence tomography. Invest Ophthalmol Vis Sci. 2010 Apr;51(4):2149-57. doi: 10.1167/iovs.09-3817. Epub 2009 Sep 24.
Friberg TR, Huang L, Palaiou M, Bremer R. Computerized detection and measurement of drusen in age-related macular degeneration. Ophthalmic Surg Lasers Imaging. 2007 Mar-Apr;38(2):126-34. doi: 10.3928/15428877-20070301-07.
Munch IC, Ek J, Kessel L, Sander B, Almind GJ, Brondum-Nielsen K, Linneberg A, Larsen M. Small, hard macular drusen and peripheral drusen: associations with AMD genotypes in the Inter99 Eye Study. Invest Ophthalmol Vis Sci. 2010 May;51(5):2317-21. doi: 10.1167/iovs.09-4482. Epub 2009 Dec 10.
Wojtkowski M, Sikorski BL, Gorczynska I, Gora M, Szkulmowski M, Bukowska D, Kaluzny J, Fujimoto JG, Kowalczyk A. Comparison of reflectivity maps and outer retinal topography in retinal disease by 3-D Fourier domain optical coherence tomography. Opt Express. 2009 Mar 2;17(5):4189-207. doi: 10.1364/oe.17.004189.
Primary Completion
February 2011
Actual (reported)Study Completion
February 2011
Actual (reported)Last Updated
June 25, 2013
Record last verified: 2013-06
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Source: ClinicalTrials.gov.
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