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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 2011

Detailed Description

Specific Objectives:

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.

Arms, Groups and Cohorts

  • Dry AMD and geographic atrophy
    • Patients diagnosed with dry AMD and geographic atrophy

Clinical Trial Outcome Measures

Primary Measures

  • Difference in mm Squared of Cirrus HD-OCT Automated Measurements of the Illumination Areaa Under the RPE to Expert Manual Measurement of Areas of Hypofluorescence Typical of Geographic Atrophy (GA).
    • Time Frame: August 2011
    • In retinal areas with atrophy, light emitted from the Cirrus penetrates the sclera and choroid which are more reflecting compared with the Retinal Pigment Epithelium (RPE). The areas with higher illumination are associated with areas of Geographic Atrophy (GA), and allow to quantify how big is the area of atrophy. The study will assess the difference between Cirrus HD-OCT measurements of areas of increased illumination under the RPE to hypofluorescence areas on fundus photos as assessed manually by retina specialists.

Participating in This Clinical Trial

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 6×6 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 Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Carl Zeiss Meditec, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Carmelina M Gordon, MD, Principal Investigator, TLC Eye Care and Laser Center
    • Eugene S Lit, M.D., Principal Investigator, East Bay Retina Consultants

References

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. Review.

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.

Yehoshua Z, Rosenfeld PJ, Gregori G, Feuer WJ, Falc√£o 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.

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