Measurement and Analysis of Macular Retinal Pigment Epithelium (RPE) Elevations With Cirrus HD-OCT vs. Color Fundus Photography
NCT ID: NCT01272063
Last Updated: 2013-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
91 participants
OBSERVATIONAL
2010-11-30
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Dry AMD with macular drusen
Patients diagnosed with dry AMD with macular drusen
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Drusen should not be combined with other lesions such as geographic atrophy (GA) or choroidal neovascularization.
* Able and willing to make the required study visits.
* Able and willing to give consent and follow study instructions.
Exclusion Criteria
* Evidence of other retinal diseases of the eye, including wet AMD, diabetic retinopathy, diabetic macular edema, or significant vitreomacular traction upon dilated examination, or upon evaluation of retinal photos.
* Thick media opacity or inability to fixate that precludes obtaining acceptable scans.
* Concomitant use of hydrochloroquine and chloroquine.
* Unable to make the required study visits.
* Unable to give consent or follow study instructions.
50 Years
ALL
No
Sponsors
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DataMed Devices Inc.
INDUSTRY
Carl Zeiss Meditec, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Philip Rosenfeld, MD
Role: PRINCIPAL_INVESTIGATOR
Bascom Palmer Eye Institute
Carmelina Gordon, MD
Role: PRINCIPAL_INVESTIGATOR
TLC Eyecare and Laser Center
Eugene Lit, MD
Role: PRINCIPAL_INVESTIGATOR
East Bay Retina Consultants
Brandon Lujan, MD
Role: PRINCIPAL_INVESTIGATOR
West Coast Retina
Locations
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East Bay Retina
Oakland, California, United States
West Coast Retina
San Francisco, California, United States
Bascom Palmer Eye Institute
Miami, Florida, United States
TLC Eyecare and Laser Centers
Lansing, Michigan, United States
Countries
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References
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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.
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.
Other Identifiers
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HD-OCT-DR-2010-1
Identifier Type: -
Identifier Source: org_study_id
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