Drusen Stage Macular Degeneration Clinical Trial
Official title:
Measurement and Analysis of Macular Retinal Pigment Epithelium (RPE) Elevations With Cirrus HD-OCT vs. Color Fundus Photography
| Verified date | June 2013 |
| Source | Carl Zeiss Meditec, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 91 |
| Est. completion date | February 2011 |
| Est. primary completion date | February 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years and older |
| Eligibility |
Inclusion Criteria: - Males or females 50 years of age or older diagnosed to have dry AMD with macular drusen. - 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: - History of retinal surgery, laser photocoagulation, and/or radiation therapy to the eye. - 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. |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | TLC Eyecare and Laser Centers | Lansing | Michigan |
| United States | Bascom Palmer Eye Institute | Miami | Florida |
| United States | East Bay Retina | Oakland | California |
| United States | West Coast Retina | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| Carl Zeiss Meditec, Inc. | DataMed Devices Inc. |
United States,
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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. — View Citation
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. — View Citation
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Munch IC, Ek J, Kessel L, Sander B, Almind GJ, Brøndum-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. — View Citation
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Varma R, Azen SP, McKean-Cowdin R, Paz SH, Torres M, Barrera J, Choudhury F, Cisneros L, Chung J, Corona E, Cuestas C, Dzekov J, Foong AW, Lastra C, Lai MY, Martinez G, Shtir C, Smith RE, Tetrow L, Wang Y, Wu J, John L, Tucker K, Klein R, Meuer SE, Knutson MD, Neider M. Four-year incidence and progression of age-related macular degeneration: the Los Angeles Latino Eye Study. Am J Ophthalmol 2010; 149(5):741-51.
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | No | |
| Primary | 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 | No | |
| Secondary | 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 | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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Study to Evaluate the Response to Supplementation With Postbiotics in Patients With Macular Degeneration.
|
N/A |