Cirrus HD-OCT Measurement of Area of Increased Light Penetration Under the Retinal Pigment Epithelium (RPE)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2011 by Carl Zeiss Meditec, Inc..
Recruitment status was Recruiting

Sponsor:

Collaborator:

DataMed Devices Inc.

Information provided by:

Carl Zeiss Meditec, Inc.

ClinicalTrials.gov Identifier:

NCT01272076

First received: January 5, 2011

Last updated: January 6, 2011

Last verified: January 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	January 5, 2011
Last Updated Date	January 6, 2011
Start Date ^ICMJE	November 2010
Estimated Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01272076 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Cirrus HD-OCT Measurement of Area of Increased Light Penetration Under the Retinal Pigment Epithelium (RPE)
Official Title ^ICMJE	Cirrus HD-OCT Measurement of Area of Increased Light Penetration Under the Retinal Pigment Epithelium (RPE)
Brief Summary	The objective of this study is to compare Cirrus HD-OCT automated measurements of the illumination area under the retinal pigment epithelium (RPE) to expert manual measurements of areas of hypofluorescence typical of geographic atrophy in fundus autofluorescence (FAF) images.
Detailed Description	Specific Objectives: 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. 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). To determine the clinical factors that affect the Cirrus HD-OCT automated measurements of the illumination area under the RPE.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Primary Care Clinic
Condition ^ICMJE	Dry AMD Geographic Atrophy
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Dry AMD and geographic atrophy Patients diagnosed with dry AMD and geographic atrophy
Publications *	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. 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. 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. 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. 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	100
Estimated Completion Date	March 2011
Estimated Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Males or females 50 years of age and older diagnosed to have advanced dry AMD with geographic atrophy. 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: 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 visit. Unable to give consent or follow study instructions.
Gender	Both
Ages	50 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01272076
Other Study ID Numbers ^ICMJE	HD-OCT-GA-2010-1-v2
Has Data Monitoring Committee	Yes
Responsible Party	Judith A. Brimacombe, Carl Zeiss Meditec, Inc.
Study Sponsor ^ICMJE	Carl Zeiss Meditec, Inc.
Collaborators ^ICMJE	DataMed Devices Inc.
Investigators ^ICMJE	Not Provided
Information Provided By	Carl Zeiss Meditec, Inc.
Verification Date	January 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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