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Completed

NCT Number: NCT01272076

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

East Bay Retina Consultants, Inc., Oakland, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Carl Zeiss Meditec, Inc.

Industry

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 7, 2011
Registry last updated
Jan 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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