Clinical trial NCT01272063: Measurement and Analysis of Macular Retinal Pigment Epithelium (RPE) Elevations With Cirrus HD-OCT vs. Color Fundus Photography
Official title: Measurement and Analysis of Macular Retinal Pigment Epithelium (RPE) Elevations With Cirrus HD-OCT vs. Color Fundus Photography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drusen Stage Macular Degeneration
Keywords: Drusen
Dry AMD
OCT
Imaging
Lead sponsor: Carl Zeiss Meditec, Inc.
Sponsor class: INDUSTRY
Collaborators: name: DataMed Devices Inc.
First posted: 2011-01-07
Enrollment: 91
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: 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).

Detailed description: This is a prospective, multiple site study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. Subjects qualified to continue will undergo color fundus photography and imaging of their study eye using the Cirrus HD-OCT.

Eligibility criteria: 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.

Primary outcomes:
measure: To compare area measurements of elevated RPE as observed in the Cirrus HD-OCT versus those designated as drusen on color fundus photographs.
timeFrame: Study was released before December 1, 2012
Secondary outcomes:
measure: To describe the clinical factors that affected the automated segmentation of elevated RPE by the Cirrus HD-OCT.
timeFrame: Study was released before December 1, 2012
Other outcomes:
measure: 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.
timeFrame: Study was released before December 1, 2012
Locations:
city: Oakland
country: United States
facility: East Bay Retina
state: California
city: San Francisco
country: United States
facility: West Coast Retina
state: California
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
city: Lansing
country: United States
facility: TLC Eyecare and Laser Centers
state: Michigan
Study officials:
affiliation: Bascom Palmer Eye Institute
name: Philip Rosenfeld, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: TLC Eyecare and Laser Center
name: Carmelina Gordon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: East Bay Retina Consultants
name: Eugene Lit, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: West Coast Retina
name: Brandon Lujan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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citation: 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.
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