Cirrus HD-OCT Measurement of Area of Increased Light Penetration Under the Retinal Pigment Epithelium (RPE)
NCT ID: NCT01272076
Last Updated: 2014-01-20
Study Results
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View full resultsBasic Information
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COMPLETED
85 participants
OBSERVATIONAL
2011-01-31
2011-02-28
Brief Summary
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Detailed Description
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1. To compare Cirrus HD-OCT automated measurements of the illumination area under the RPE to expert manual measurements of areas of hypofluorescence typical of geographic atrophy in fundus autofluorescence (FAF) images.
2. To describe the differences and similarities between Cirrus HD-OCT and fundus autofluorescence images of subjects with geographic atrophy secondary to dry age-related macular degeneration (AMD).
3. To determine the clinical factors that affect the Cirrus HD-OCT automated measurements of the illumination area under the RPE.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Dry AMD and geographic atrophy
Patients diagnosed with dry AMD and geographic atrophy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Geographic atrophy lesions should:
* Not be greater than 5 mm at the widest diameter. The entire lesion(s) should fit into the 6x6 mm scan area of the Cirrus HD-OCT.
* Not be smaller than 1.25 mm2.
* Not be confluent with peri-papillary atrophy.
* Not be combined with other lesions such as CNVs.
* Able and willing to make the required study visit.
* 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 visit.
* Unable to give consent or follow study instructions.
50 Years
ALL
No
Sponsors
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Carl Zeiss Meditec, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Carmelina M Gordon, MD
Role: PRINCIPAL_INVESTIGATOR
TLC Eye Care and Laser Center
Eugene S Lit, M.D.
Role: PRINCIPAL_INVESTIGATOR
East Bay Retina Consultants
Locations
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East Bay Retina Consultants, Inc.
Oakland, California, United States
TLC Eyecare and Laser Centers
Jackson, Michigan, United States
Countries
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References
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Schmitz-Valckenberg S, Fleckenstein M, Scholl HP, Holz FG. Fundus autofluorescence and progression of age-related macular degeneration. Surv Ophthalmol. 2009 Jan-Feb;54(1):96-117. doi: 10.1016/j.survophthal.2008.10.004.
Holz FG, Bindewald-Wittich A, Fleckenstein M, Dreyhaupt J, Scholl HP, Schmitz-Valckenberg S; FAM-Study Group. Progression of geographic atrophy and impact of fundus autofluorescence patterns in age-related macular degeneration. Am J Ophthalmol. 2007 Mar;143(3):463-72. doi: 10.1016/j.ajo.2006.11.041. Epub 2006 Dec 22.
Hwang JC, Chan JW, Chang S, Smith RT. Predictive value of fundus autofluorescence for development of geographic atrophy in age-related macular degeneration. Invest Ophthalmol Vis Sci. 2006 Jun;47(6):2655-61. doi: 10.1167/iovs.05-1027.
Lujan BJ, Rosenfeld PJ, Gregori G, Wang F, Knighton RW, Feuer WJ, Puliafito CA. Spectral domain optical coherence tomographic imaging of geographic atrophy. Ophthalmic Surg Lasers Imaging. 2009 Mar-Apr;40(2):96-101. doi: 10.3928/15428877-20090301-16.
Sunness JS, Margalit E, Srikumaran D, Applegate CA, Tian Y, Perry D, Hawkins BS, Bressler NM. The long-term natural history of geographic atrophy from age-related macular degeneration: enlargement of atrophy and implications for interventional clinical trials. Ophthalmology. 2007 Feb;114(2):271-7. doi: 10.1016/j.ophtha.2006.09.016.
Yehoshua Z, Rosenfeld PJ, Gregori G, Feuer WJ, Falcao M, Lujan BJ, Puliafito C. Progression of geographic atrophy in age-related macular degeneration imaged with spectral domain optical coherence tomography. Ophthalmology. 2011 Apr;118(4):679-86. doi: 10.1016/j.ophtha.2010.08.018. Epub 2010 Oct 29.
Other Identifiers
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HD-OCT-GA-2010-1-v2
Identifier Type: -
Identifier Source: org_study_id
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