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OpenTrials
Completed

NCT Number: NCT01890174

Repeatability and Reproducibility of Cirrus HD-OCT Macular Retinal Pigment Epithelium Elevation

The objective of this study is to determine the repeatability and reproducibility of the Cirrus HD-OCT measurements of drusen area and volume.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northern California Retina Vitreous Associates

Mountain View, California, 94040, United States

About this study

This is a prospective, single site study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. The study will be divided into two phases. In Phase 1, the inter-device variability of Cirrus HD-OCT measurements of drusen area and volume will be determined. In Phase 2, the inter-operator variability of Cirrus HD-OCT measurements of drusen area and volume will be determined. In each of these phases, the Macular Cube 200 x 200 scan and the Macular Cube 512 x 128 scan will be evaluated.

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.
  • Thick media opacity or inability to fixate that precludes obtaining acceptable scans.
  • Concomitant use of hydrochloroquine or chloroquine.
  • Unable to make the required study visits.
  • Unable to give consent or follow study instructions.

Treatment and study plan

Primary outcomes

  1. Coefficient of variation for area (mm^2) of RPE elevation measurements in the central 3 mm circle.

    Time frame: Single visit observation

Secondary outcomes

  1. Coefficient of variation for volume (mm^3) of RPE elevation measurements in the central 3 mm circle.

    Time frame: Single visit observation

Other outcomes

  1. Coefficient of variation for area (mm^2) of RPE elevation measurements in the central 5 mm circle.

    Time frame: Single visit observation

  2. Coefficient of variation for volume (mm^3) of RPE elevation measurements in the central 5 mm circle.

    Time frame: Single visit observation

Sponsors and collaborators

Lead sponsor

Carl Zeiss Meditec, Inc.

Industry

Collaborators

  • DataMed Devices Inc.

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 1, 2013
Registry last updated
Jul 1, 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.