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OpenTrials
Completed

NCT Number: NCT01272063

Measurement and Analysis of Macular Retinal Pigment Epithelium (RPE) Elevations With Cirrus HD-OCT vs. Color Fundus Photography

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).

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Key information

Conditions

Drusen Stage Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

East Bay Retina, Oakland, California, United States

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About this study

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.

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 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.

Treatment and study plan

Primary outcomes

  1. To compare area measurements of elevated RPE as observed in the Cirrus HD-OCT versus those designated as drusen on color fundus photographs.

    Time frame: Study was released before December 1, 2012

Secondary outcomes

  1. To describe the clinical factors that affected the automated segmentation of elevated RPE by the Cirrus HD-OCT.

    Time frame: Study was released before December 1, 2012

Other outcomes

  1. 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.

    Time frame: Study was released before December 1, 2012

Sponsors and collaborators

Lead sponsor

Carl Zeiss Meditec, Inc.

Industry

Collaborators

  • DataMed Devices Inc.

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 7, 2011
Registry last updated
Jun 25, 2013

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.